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

Model Number	134044
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2020
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 an open hepatectomy, while on hepatic vessel, there were issues experienced with loading/firing of the clips.No clips able to be load properly into the jaws at any point during use.The device was replaced to complete the procedure.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was returned for evaluation.Inspection showed one of the jaw legs was misaligned.The instrument was received fully applied.Functionally, when test fired the clip was ejected from the jaws unformed.The jaw and handle moved smoothly through the firing cycle, returned to the open position, and interlock engaged appropriately.It was reported that the clips would not load properly.A device-related causal link was confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur if a side-load is applied to one of the jaw legs or if the device is applied over an obstruction during clinical application.The manufacturing records for each device are also thoroughly reviewed prior to release to ensure that products meet all medtronic quality specifications.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: 9771183
• Report Number: 2647580-2020-00779
• Device Sequence Number: 14285945
• Product Code: FZP
• UDI-Device Identifier: 10884521057531
• UDI-Public: 10884521057531
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K853650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2020

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: 03/31/2024
• Device Model Number: 134044
• Device Catalogue Number: 134044
• Device Lot Number: P9D1392Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2020
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 06/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1