MAUDE Adverse Event Report: US SURGICAL PUERTO RICO PREMIUM SURGICLIP II; CLIP, IMPLANTABLE

Model Number 134053

Device Problems Fail-Safe Problem (2936); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the clips were not loading properly.Functional testing confirmed the clips were not advancing in the clip track.The device was disassembled, and dents were noted on the follower component.A review of the device history record indicates this product was released meeting all medtronic quality release specifications at the time of manufacture.However, a manufacturing fault was identified during product analysis.The root cause of the observed condition was determined to be a result of a manufacturing activity.Improvements have been initiated to mitigate this condition.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during cephalic duodeno-pancreatectomy, the surgeon was not able to squeeze the handle.A new device was used to complete the procedure.There was no patient injury.

• Brand Name: PREMIUM SURGICLIP II
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 10540517
• MDR Text Key: 207138048
• Report Number: 2647580-2020-02971
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057579
• UDI-Public: 10884521057579
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K143644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 134053
• Device Catalogue Number: 134053
• Device Lot Number: P9K1261Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1