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

Model Number	134046
Medical Device Problem Codes	Mechanical Problem (1384); Mechanics Altered (2984)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2019
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 flap surgery, while ligating small vessels, the surgeon experienced issues in loading and firing of the clips.It was noted that clips deployed from the device were malformed.Same issue occurred when the surgeon used a second clip applier of the same kind.Surgeon used a third clip applier to complete the case.No patient injury.
Additional Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of two devices.The first instrument was received partially applied with sixteen remaining clips.The second instrument was received partially applied with three remaining clips.Visual inspection of the instruments revealed no abnormalities.Functionally, the instruments were fired once in air and proper clip formations were confirmed.The remaining clips were then fired on test media with proper formations.The jaws and handles moved smoothly through their firing cycles and returned to the open positions and each remaining clip loaded properly in the jaws.When the cartridges were empty, the interlocks 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.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.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: 8771957
• Report Number: 2647580-2019-03559
• Device Sequence Number: 1708030
• Product Code: FZP
• UDI-Device Identifier: 10884521057548
• UDI-Public: 10884521057548
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2019

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: 07/31/2023
• Device Model Number: 134046
• Device Catalogue Number: 134046
• Device Lot Number: P8G0314CX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1