MAUDE Adverse Event Report: TELEFLEX WECK HEMOLOK L CLIPS 6/CART 84/BOX; LIGATING CLIPS

Catalog Number 544240

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2014

Event Type  malfunction  

Event Description

Alleged issue: during a laparoscopic right surrenalectomy (adrenalectomy) surgery, the principal surrenal vein was located to be sectioned between 2 clips.The clips in this cartridge did not work, they did not close.The pt's condition is fine.

Manufacturer Narrative

A device history record (dhr) review did not show issues related to complaint.The complaint cannot be confirmed since the sample was not returned.The mfr will continue to monitor and trend relating complaints.

• Brand Name: WECK HEMOLOK L CLIPS 6/CART 84/BOX
• Type of Device: LIGATING CLIPS
• Manufacturer (Section D): TELEFLEX; rtp NC 27709
• Manufacturer (Section G): TELEFLEX; prolongacion mission eusebio; MX
• Manufacturer Contact: doris sturgis, specialist ; po box 12600; rtp, NC 27709 ; 9194334953
• MDR Report Key: 4180343
• MDR Text Key: 17689094
• Report Number: 3003898360-2014-00826
• Device Sequence Number: 1
• Product Code: MCH
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 544240
• Device Lot Number: 01B1400269
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1