MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ACUCLIP; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	OMS-A8
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2018
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 kidney transplant procedure, the device had issues with the loading or firing of the clips, wherein the clips were unable to be loaded properly into the jaws at any point during use.A new device was opened in order to resolve the issue.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 sixteen clips remaining.There were no visual or functional abnormalities noted during pmv testing.The remaining clips were fired on test media with proper formation.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.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACUCLIP
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 7357922
• Report Number: 2647580-2018-01417
• Device Sequence Number: 19137790
• Product Code: GCJ
• UDI-Device Identifier: 20884521057514
• UDI-Public: 20884521057514
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K920599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2018

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: 08/31/2022
• Device Model Number: OMS-A8
• Device Catalogue Number: OMS-A8
• Device Lot Number: P7H1413CX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2018
• Initial Date Received by Manufacturer: 03/01/2018
• Supplement Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 03/21/2018
• Supplement Report FDA Received Date: 06/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1