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	05/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
It was reported that "a popped rivet was identified during repair at msi".No patient involvement.
Additional Manufacturer Narrative
Qn #(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 june of 2022 from lot number 06d2247826 (06d2247826-037).The investigation determined that the manufacturing processes adhered to approved specifications, utilizing the correct materials and components.A thorough visual and functional inspection was conducted, revealing that the jaws and outer tube were misaligned and bent, leading to the rivet becoming dislodged.This malfunction resulted in the jaws detaching from the outer tube, causing misalignment that prevented proper loading of the clip, thereby rendering the device nonfunctional.While the exact cause of the misalignment and rivet dislodgement could not be conclusively identified, excessive force during use at the end user's facility is suspected.Notably, all 50 instruments from this lot underwent 100% visual inspection and functional testing prior to shipment, in accordance with standard operating procedures 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.

• 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: 22133353
• Report Number: 3011137372-2025-00194
• Device Sequence Number: 12864008
• Product Code: GDO
• UDI-Device Identifier: 34026704623625
• UDI-Public: (01)34026704623625(11)220715(17)001231(10)06D2247826(21)
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 05/14/2025

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: 06D2247826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2022
• 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