MAUDE Adverse Event Report: TELEFLEX MEDICAL WECK AUTO ENDO5 ML; CLIP, IMPLANTABLE

Catalog Number	AE05ML
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "a malfunction occurred during reloading after preloading." no patient harm or injury reported.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).One unit of auto endo5 ml (p/n ae05ml, lot 73d2500641, serial no.(b)(6)) was returned for investigation following a report of "clip(s) not loading properly." visual examination of the returned device identified a sink mark on the lower portion of the handle frame and outwardly bent feed centering tabs on the channel box.The trigger was returned partially engaged, and the feeder tip was present in the jaws.Evidence of use, including biological material, was present on the device.Dimensional inspection of the observed sink mark was performed by research & development (r & d) using calibrated optical measurement equipment.The sink mark measured 0.00348 inches in depth, which is within the allowable specification of 0.005 inches per drawing.Functional evaluation showed that the feeder was stuck and unable to reset to load clips.The trigger could not fully reset and did not consistently engage the ratchet, and no clips were released during repeated trigger actuation.The device was disassembled for further evaluation.The trigger ears were confirmed to be broken.The ratchets were properly greased, and no defects were observed in the knob, jaw assemblies, feeder, feeder tip, or outer tubing.One clip released during disassembly, and the clips were confirmed not to be stacked.Eight clips remained in the channel, indicating partial use prior to return.The feed centering tabs on the channel box were bent outward; however, the cause of the bent tabs could not be conclusively attributed to either user handling or supplier-related factors.Based on the inspection and disassembly findings, the primary failure mode was identified as broken trigger ears, which prevented proper feeder and trigger operation.The observed sink mark was determined to be within specification and not contributory to the reported issue.A device history record (dhr) review was conducted for lot 73d2500641 (manufactured 04/16/2025; released 05/14/2025; (b)(4) units produced) and did not identify any manufacturing nonconformances related to the complaint.The device was manufactured prior to corrective actions implemented under internal nonconformance, which was closed on (b)(6) 2025.The applicable instructions for use were reviewed and state that mishandling of appliers may result in improper load and/or closure of the ligating clip.Based on the investigation, the reported complaint of "clip(s) not loading properly" was confirmed.The confirmed failure mode was broken trigger ears.The root cause of the broken trigger ears could not be conclusively determined based on the available information.Teleflex will continue to monitor and trend complaints of this nature.Other remarks: corrected data.
Event or Problem Description
It was reported that "a malfuntion occurred during reloading after preloading." no patient harm or injury reported.

• Brand Name: WECK AUTO ENDO5 ML
• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23723122
• Report Number: 3003898360-2025-00891
• Device Sequence Number: 18694280
• Product Code: FZP
• UDI-Device Identifier: 14026704553126
• UDI-Public: (01)14026704553126(11)250416(17)261014(10)73D2500641(21)
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K230480
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2025

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: AE05ML
• Device Lot Number: 73D2500641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown