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

Model Number 134053

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during open kidney transplant procedure, while the doctor was using the device, a few clips deployed and did attach but 2 at a time and then jammed.This happened on the three devices that were tried using and when the fourth clip applierwas opened the case was completed.There was no patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of two devices.The first instrument was received partially applied with twenty-eight remaining clips.The second instrument was received partially applied with twenty-seven remaining clips.Visual inspection of both instruments revealed no abnormalities.Functionally, the instruments handles were cycled and the pusher bars and jaws did not function.The instruments were disassembled for observation of the internal components, and the pusher bar links were disengaged.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the disengaged pusher bar link may occur when excessive force is applied to the handles during or after the firing cycle causing the link to disengage.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

• 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: 8672991
• MDR Text Key: 147166751
• Report Number: 2647580-2019-02869
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057579
• UDI-Public: 10884521057579
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K853650
• 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,Followup
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 134053
• Device Catalogue Number: 134053
• Device Lot Number: P8K1749Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2018
• 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
• Patient Age: 57 YR