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Central Drugs Standard Control Organization
Directorate General of Health Services
Ministry of Health and Family Welfare
Government of India
(Medical Devices and Diagnostics Division)
Email: ddcimd-cdsco@nic.in
Food & Drugs Administration Bhawan,
Kotla Road, New Delhi.
F.No.29/Misc/03/2021-DC (355) Date: 14th June 2022
MEDICAL DEVICE ALERT
DEVICE
EEA Auto Suture Circular Stapler/ Loading unit with DST Series Technology
(Staple)
BACKGROUND
The DST Series™ EEA™ stapler is used throughout the alimentary tract for the
creation of end-to end, end-to side, and side-to-side anastomoses in both open and
laparoscopic surgeries.
Distributed 25mm EEA Auto suture Circular Staplers with DST Series Technology, with
model numbers EEA25, EEAXL25, EEA2535, and EEAXL2535, have the potential for
the staple guide to not be securely attached to the instrument. This issue is related
only to the 25mm EEA Auto suture Circular Staplers with DST Series Technology. No
other Medtronic products or other sizes of EEA Auto suture Circular Staplers with DST
Series Technology are affected by this issue.
Reason for Recall
A staple guide not attached to the instrument could cause the component to
disengage and if disengaged, could allow the device to transect tissue without
forming staples. This could result in delay of treatment, extended hospital stays,
unspecified tissue injury, unintended radiation exposure, unexpected medical
intervention, foreign body in patient, failure to anastomose, and hemorrhage.
Who May Be Affected
Patients going for surgical procedures with the DST series EEA stapler used
throughout the alimentary tract for the creation of end to end, end-to side,
and side-to-side anastomoses in both open and laparoscopic surgeries.
Important Note: CDSCO have not received any complaints from the market on this issue.
Page 1 of 2FURTHER DETAILS & CONTACTS
M/s India Medtronic Pvt. Ltd, Gurugram, Haryana had issued a Field Safety Notice
which is attached herewith this alert.
M/s India Medtronic Pvt. Ltd.
4th Floor, Tower A & B SAS Tower
Medanta The Medicity Complex
Sector 38, Gurugram 122001
Haryana, India
www.medtronic.co.in
Tel +91-124-4709800
Fax +91-124-4206850
Page 2 of 2FIELD SAFETY CORRECTIVE ACTION NOTIFICATION (FSCA) FORM
1. Before filling this form, the reporter collects and collates the prescribed information in the form.
2. This form will serve as the reporting tool in lieu with the Medical Devices Rules, 2017.
Fourth Schedule
[See rule 20(2), 21(2), 34(2), 63(1) and 64(1)] Part II (ii) (b) and Appendix II for intimating, notifying CDSCO for
any Field Safety Corrective Action (FSCA) in relation to medical device product recall and other corrective action.
3. A scanned signed copy of PDF version of this form is to be sent to CDSCO via email to dci.nic.in
4. Additional information that may be pertinent for the completion of this form can be provided as an attachment.
5. All the field safety notices will be published on the CDSCO website and the reporter holds the full responsibility for the
information contained in the Field Safety Notification and reporter must indemnify CDSCO for all losses, claims, demands,
liabilities, causes of action, expenses of any ki nd arising from CDSCO’s publication of the FSN.
Primary Information
Type of Field Safety Corrective Product Recall
1.
Action (FSCA)
Other Corrective actions
Type of Report
Notification
2.
Preliminary Report
Final Report
10-May-2022
3. Date of Report (dd/mm/yy)
4. Reference Number
(auto generated by system)
Particulars of Reporters
Latika Vats
1. Contact Person Name
Director-Regulatory Affairs and Quality Assurance
2. Job Title
+917227907498
3. Telephone Numbers
rs.indiaregulatory@medtronic.com
4. Email Address
Medtronic
5. Office Address
India Medtronic Pvt Ltd, 4t Floor, Tower A & B, SAS Tower, Medanta
The Medicity complex Sector 38, Gurugram 122001, Haryana India
Same as above
6. Local Contact Details
(if reporter not based in India)Device General Information
EEA Auto Suture Circular Stapler/ Loading unit with DST Series
1. Device Name
Technology (Staple)
Accessories / Associated NA
2.
Devices Affected
The DST Series™ EEA™ stapler is used throughout the alimentary tract
3. Device Intended Use
for the creation of end-to end, end-to side, and side-to-side
anastomoses in both open and laparoscopic surgeries.
Regulatory Details
Other than India
1. Device Regulatory Status Is the device registered globally
Yes No
Is the device marketed globally
Yes No
If yes provide details:
In India
1. Device Regulatory Status Is the device registered in India
Yes No
Is the device marketed in India
Yes No
If yes provide details : IMP/MD/2018/000215
Legal Manufacturing Site : M/s Covidien IIc, 15 Hampshire Street,
2. Manufacturer(s) and Contact
Mansfield, MA 02048, Country: United States Telephone No.: 303-305-
Details
2841 FAX: 303-305- 2212 E-Mail : Michael.Aymami@covidien.com
Actual Manufacturing Site : M/s Covidien, Building 911-67, Sabanetas
3. Product License Holder / Local
Industrial Park, Ponce, Puerto Rico 00731, Country: United States
Authorized Representative
Telephone No.: 787-259-6505 FAX: 787- 259-1485 E-Mail : carlos.
Name & Address rodriguez@medtronic.com
M/s India Medtronic Private Limited, Plot No 609 Survey/Shed-188
4. Importer(s) / Distributor(s)
(part) Chamunda Compound,Kasheli Village, Dist Thane, Bhiwandi
and Contact Details 421301 Maharashtra , Thane, Maharashtra (India) - 421301
Telephone No.: 22330747001 FAX: 22330747001
Impacted Device Information
Please refer attachment#1 FA1245
1. Model Number
Not applicable
2. Catalogue Number
Not Applicable
3. Serial Number
Please refer attachment#1 FA1245
4. Affected Lot / Batch Number
NA
5. UDI Number
NA
6. Accessories / Associated
Devices AffectedDevice Related to FSCA Information
1. Number of affected Unit Manufactured in India
Period : NA
Imported into India- 2625
Period : Jun 2017 to Feb 2022
Supplied in India- 2408
Period : Jun 2017 to May 2022
Expected Shipment to India- NA
Expected Date of Arrival: NA
Please refer attachment#1 FA1245
2. Number of affected units
supplied to each consignee
3. FSCA Strategy gk • A voluntary FCA will be implemented to communicate the
issue to all consignees who have received affected product
according to Medtronic records.
• Consignees will be asked to confirm receipt of FCA
notification.
• Consignees, including Medtronic field representatives, will
be asked to return all unused affected sold product within
their possession.
• Reconciliation of returned product will be managed per
Product Hold Order
4. Did the FSCA arise due to an ☒ Yes No
adverse event ?
5. If yes, what is the category of
☐
Serious Public Health Threat
adverse event ?
☐
Death
☒
Serious Injury
☐
Non-Serious Injury
6. Did this adverse event occur in ☒
Yes
☐
No
India ?
If Yes then adverse event Ref. No. & Summary : N/A
Risk Summary and Acceptability
7. Evaluation of risk associated
with affected device (Health The overall risk falls into Zone 1 and Zone 2 for the potential harms
Hazard Evaluation Report) of failure to anastomose, unspecified tissue injury,
hemorrhage/bleeding, delay to treatment/therapy, unexpected
medical intervention, foreign body in patient, and unintended
radiation exposure. The highest potential of harm is a severity of 4.
The scoring of this IIA reflects the full risk of harm (severity of 4).8. Give reason & detail for FSCA
(if other than the adverse Not Applicable
event)Affected Device Details (e.g. device identifiers, lot/batch No.) listed in the FSCA
Communication
For Other than India
Yes
1. Has the FSCA communication
been sent to all consignees ?
13-May-22
2. Date of commencement of FSCA
by product owner (dd/mm/yyy)
13-May-22 to 30-May-22
3. Date of commencement of FSCA (if
applicable)
Information Awaited
4. Countries to which FSCA has been
reported (if any)
21-Jul-2023
5. Proposed date of completion of FSCA
(if applicable)
6. Summary of root cause analysis
CAPA2022-018332 was issued to investigate the root cause of the issue
CAPA2022-018332 was issued to investigate the root cause of the issue
7. Summary of Corrective and
Preventive Action (CAPA)
For India
Please refer attachment#1 FA1245
1. Affected device details
2. Has the FSCA communication ☒ Yes, Date Sent : No
been sent to all consignees ?
(dd/mm/yyy)
(dd/mm/yyy)
Expected Date to be sent : 25-May-2022
13- May-2022
3. Date of commencement of FSCA
by product owner (dd/mm/yyy)
25-May-2022
4. Date of commencement of FSCA in
India (if applicable)
Information Awaited
5. Countries to which FSCA has been
reported (if any)
21-Jul-2023
6. Proposed date of completion of FSCA
(if applicable)CAPA2022-018332 was issued to investigate the root cause of the issue
7. Summary of root cause analysis
CAPA2022-018332 was issued to investigate the root cause of the issue.
8. Summary of Corrective and
Preventive Action (CAPA)
Change Notification (if applicable)
No change in software, design or labelling
1. Type of change (software
change, design change,
labelling)
2. For software change, have any Yes No
feature not related to FSCA
incorporates If Yes then provide details :
Other Information
I attested that the information submitted is true and accurate and that I am authorized to submit this form
in behalf of company.
Signature : ………………………………………………….
Name of reporting person : Latika Vats (Director-Regulatory Affairs and Quality Assurance)
Date of Notification : ………………………………………………….