MAUDE Adverse Event Report: Teleflex Medical Weck Hem-o-lok Auto Endo5 ML; CLIP, IMPLANTABLE

Catalog Number	AE05ML
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction

• Brand Name: Weck Hem-o-lok 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 27560
• MDR Report Key: 50845934
• Report Number: 3003898360-2026-00415
• Device Sequence Number: 13329670
• Product Code: FZP
• UDI-Device Identifier: 24026704695892
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K230480
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2026

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
• Device Catalogue Number: AE05ML
• Device Lot Number: 73F2501027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2025
• 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
• Patient Sex: Unknown