MAUDE Adverse Event Report: TELEFLEX WECK HEMOLOCK XL CLIPS 6/CART 84/BOX; LIGATING CLIPS

Catalog Number 544250

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2014

Event Type  malfunction  

Event Description

Complaint alleges: during a laparoscopic appendectomy, while clipping the appendix, the doctor attempted to close the clip, which would not close.The clip was closed by using another clip.No pt injury reported.Pt current condition reported, as fine.

Manufacturer Narrative

A device history record (dhr) review did not show any issues related to this complaint.A visual or functional inspection of the product involved in the complaint could not be conducted since the product was not returned.Complaint can not be confirmed since the sample was not available for investigation, therefore, it is not possible to determine the root cause for the defect reported and a corrective action for it.The mfr will continue to monitor trending relating complaints.

• Brand Name: WECK HEMOLOCK XL CLIPS 6/CART 84/BOX
• Type of Device: LIGATING CLIPS
• Manufacturer (Section D): TELEFLEX; tecate ; MX
• Manufacturer (Section G): TELEFLEX; prolongacion mision eusebio
• Manufacturer Contact: jasmine brown, regulatory affairs ; po box 12600; rtp, NC 27709 ; 9193614124
• MDR Report Key: 3963698
• MDR Text Key: 20266961
• Report Number: 3003898360-2014-00294
• Device Sequence Number: 1
• Product Code: MCH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 544250
• Device Lot Number: 01E1300041
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1