MAUDE Adverse Event Report: TELEFLEX MEDICAL WECK HEM-O-LOK; CLIP, IMPLANTABLE

Lot Number 73G2200750

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 12/19/2022

Event Type  malfunction  

Event Description

Clips broke during procedure.

• Brand Name: WECK HEM-O-LOK
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL
• MDR Report Key: 16185678
• MDR Text Key: 307662246
• Report Number: MW5114335
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/19/2023

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 Operator: Health Professional
• Device Lot Number: 73G2200750
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1