MAUDE Adverse Event Report: TELEFLEX HEMOLOK L CLIPS 6/CART; HEMOLOK CLIP

Catalog Number 544240

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2014

Event Type  malfunction  

Event Description

Alleged event: during robotic prostatectomy, the doctor had issues with the clip twisting and not locking into place.The patient's condition is reported as fine.

Manufacturer Narrative

The device history review for the product hemolok l clips 6/cart 84/box, lot #73f1400318 did not show issues related to the complaint.The manufacturer will continue to monitor and trend related complaints.

• Brand Name: HEMOLOK L CLIPS 6/CART
• Type of Device: HEMOLOK CLIP
• Manufacturer (Section D): TELEFLEX; rtp NC 27709
• Manufacturer Contact: effie jefferson, rn ; 3015 carrington mill blvd.; morrisville, NC 27506 ; 9194332672
• MDR Report Key: 4373727
• MDR Text Key: 19969905
• Report Number: 3003898360-2014-00968
• Device Sequence Number: 1
• Product Code: MCH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 544240
• Device Lot Number: 73G1400318
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/05/2014
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1