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

Catalog Number	AE05ML
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "was able to load clip into jaws, unable to clip around vessel, applier would not work.Same lot number used multiple times today without incident.Manual hol used instead." no patient harm or injury reported.The patient's status is reported as "fine.".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.If the sample becomes available at a later date a follow-up report will be submitted with investigation results.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
(b)(4).Upon further review of the investigation report, it was determined that this was not a reportable event; thus, the initial mdr submitted on 17-december-2025 should be retracted.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.If the sample becomes available at a later date a follow-up report will be submitted with investigation results.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 "was able to load clip into jaws, unable to clip around vessel, applier would not work.Same lot number used multiple times today without incident.Manual hol used instead." no patient harm or injury reported.The patient's status is reported as "fine.".

• 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: laura guadalupe gonzalez ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23831385
• Report Number: 3003898360-2025-00915
• Device Sequence Number: 4992910
• Product Code: FZP
• UDI-Device Identifier: 14026704553126
• UDI-Public: (01)14026704553126(11)250516(17)261113(10)73E2500402(21)
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K230480
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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: 73E2500402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2025
• 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