MAUDE Adverse Event Report: TELEFLEX MEDICAL WECK AUTO ENDO5 AUTOMATIC HEM-O-LOK CLIP APPLIRE; CLIP IMPLANTABLE

Model Number REF AE05L

Device Problems Defective Device (2588); Firing Problem (4011)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/08/2019

Event Type  malfunction  

Event Description

Defective - kept locking up so md couldn't get a clean fire.Had to remove several clips from pt.Ultimately, used a metal ligaclip applier with clips.

• Brand Name: WECK AUTO ENDO5 AUTOMATIC HEM-O-LOK CLIP APPLIRE
• Type of Device: CLIP IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL ; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 8565212
• MDR Text Key: 143680950
• Report Number: MW5086266
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2021
• Device Model Number: REF AE05L
• Device Lot Number: 73L1800097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 51 YR