MAUDE Adverse Event Report: TELEFLEX MEDICAL WECK HOL ML 5MM ENDO APPLIER; APPLIER, SURGICAL, CLIP

Catalog Number	544965
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "a popped rivet was identified during repair at msi".No patient involvement.
Additional Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
(b)(4).The sample was 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 october of 2017 from lot number 06c1749054.It was found that this order was made from the correct materials and components, and all approved processes were followed.A visual and functional inspection was conducted, and it was found that the jaws of the device are broken/bent due to excessive force applied by end user, resulting in the device to be defective and non-functional.All (b)(4) instruments from this lot were 100% 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 for reports of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "a popped rivet was identified during repair at msi".No patient involvement.

• Brand Name: WECK HOL ML 5MM ENDO APPLIER
• 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: 21619901
• Report Number: 3011137372-2025-00085
• Device Sequence Number: 20966460
• Product Code: GDO
• UDI-Device Identifier: 34026704623625
• UDI-Public: (01)34026704623625(11)171019(17)221128(10)06C1749054(21)
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 02/25/2025

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 Expiration Date: 11/28/2022
• Device Catalogue Number: 544965
• Device Lot Number: 06C1749054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2017
• 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