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

Model Number	134031
Medical Device Problem Codes	Fail-Safe Problem (2936); Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the instrument was fully applied with no clips remaining.The distal end of the channel cover was intact.Microscopic inspection of the jaws revealed acceptable jaw co-planarity.Functional testing noted that the instrument was cycled to complete the firing cycle, the interlock did not engage.The pusher bar was dragging the interlock mechanism backwards.It was reported that the safety interlock deployed prior to all staples or clips firing.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: the interlock was nonfunctional and did not engage.The most likely cause was determined to be manufacturing related.This product is no longer being manufactured.The event had foreseen risks and is included in a data monitoring plan.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during an open procedure, on the firing step, the surgeon was unable to squeeze the handle, the clip applier blocked before loading.Another device was opened to resolve the issue.There was no patient injury.

• Brand Name: PREMIUM SURGICLIP
• Common Device Name: 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 13843759
• Report Number: 2647580-2022-00931
• Device Sequence Number: 4132306
• Product Code: FZP
• UDI-Device Identifier: 20884521057521
• UDI-Public: 20884521057521
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K143644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/21/2022

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: 12/31/2024
• Device Model Number: 134031
• Device Catalogue Number: 134031
• Device Lot Number: P0A1215Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown