MAUDE Adverse Event Report: TELEFLEX MEDICAL WE; APPLIER, SURGICAL, CLIP

Catalog Number	544965
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that during use on a laparoscopic nephrectomy, the jaws of the applier were misaligned.The patient status is reported as "ok".
Additional Manufacturer Narrative
(b)(4).The sample was not returned to the manufacturer for evaluation.The manufacturer reported: "per customer provided information the dhr for the alleged defective medical device was reviewed and found complete without any irregularities.The alleged defective instrument was produced at the tecomet, inc.Kenosha, wl facility as part of a (b)(4) pc.Lot in january of 2024 from lot number 06d2360037.It was found that this order was made from the correct materials and components, and all approved processes were followed.This instrument has not been returned for review or evaluation therefore we are unable to determine what may have caused the alleged defect or validate the alleged complaint.Even with proper handling, correct care, and maintenance; reusable instruments should not be expected to last indefinitely and should be replaced at any sign of wear and/or damage.Tecomet is closing this complaint since the device has not been returned within the established timeframe.Complaints may be reopened for further investigation should the device be returned at a later date.All instruments are visually inspected, and function tested prior to shipment to the customer as this is a standardized procedure at this facility for this product line.Due to these findings, no further actions will be taken in response to this complaint, and this record will be deemed closed." teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that during use on a laparoscopic nephrectomy, the jaws of the applier were misaligned.The patient status is reported as "ok".

• Brand Name: WE
• Common Device Name: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23147245
• Report Number: 3011137372-2025-00350
• Device Sequence Number: 8846919
• Product Code: GDO
• UDI-Device Identifier: 34026704623625
• UDI-Public: (01)34026704623625(11)240216(17)001231(10)06D2360037(21)
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

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 Catalogue Number: 544965
• Device Lot Number: 06D2360037
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown