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

Catalog Number AE05ML

Device Problem Defective Device (2588)

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

Event Date 08/15/2019

Event Type  malfunction  

Event Description

During laparoscopic surgery, surgeon went to clip the cystic duct, clip applier did not work.

• Brand Name: WECK
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 9075532
• MDR Text Key: 158853702
• Report Number: 9075532
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/27/2019

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: No Information
• Device Catalogue Number: AE05ML
• Device Lot Number: 73D1900014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/27/2019
• Date Report to Manufacturer: 09/17/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1