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

Model Number	134046
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a procedure, the surgeon could squeeze the jaws and clips were able to be loaded properly, but the clips could not be formed correctly as the jaws were twisted.Another device was used to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The instrument was received partially applied with four remaining clips.Microscopic inspection of the instrument revealed that the jaws were misaligned.Functionally, the instrument was fired once in air and a scissored clip formation was observed.The remaining clips were then fired on test media and scissored clip formation was observed.The jaw and handle moved smoothly through the firing cycle and returned to the open position and each remaining clip loaded properly in the jaw.When the cartridge was empty, the interlock engaged and prevented the jaw from approximating.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 misaligned jaws and/or scissored clips condition may occur if the distal end of the device is subjected to excessive manipulation during application of the instrument.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
• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 8268215
• Report Number: 2647580-2019-00457
• Device Sequence Number: 2120441
• Product Code: FZP
• UDI-Device Identifier: 20884521057545
• UDI-Public: 20884521057545
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K853650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 134046
• Device Catalogue Number: 134046
• Device Lot Number: P7D1146CX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Initial Date Received by Manufacturer: 12/28/2018
• Supplement Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 01/22/2019
• Supplement Report FDA Received Date: 03/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1