MAUDE Adverse Event Report: TELEFLEX HEMOLOK ML CLIPS 6/CART 84/BOX; HEMOLCIPS

Catalog Number 544230

Device Problems Material Disintegration (1177); Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2014

Event Type  malfunction  

Event Description

Alleged event: during surgery, the surgeon noticed green fragments on the gall bladder that appeared to be fragments from the clip cartridge.No patient injury.Patient's condition reported as fine.

Manufacturer Narrative

The device history record review (dhr) for the product hemolok ml clips 6/cart 84/box, lot # 01b1400542 was manufactured on 03/03/2014 a total of (b)(4) pieces.Dhr investigation did not show issues related to complaint.Device sample received by manufacturer, but investigation is still underway at time of this report.

• Brand Name: HEMOLOK ML CLIPS 6/CART 84/BOX
• Type of Device: HEMOLCIPS
• Manufacturer (Section D): TELEFLEX; tecate ; MX
• Manufacturer Contact: effie jefferson, rn ; po box 12600; durham, NC 27709 ; 9194332672
• MDR Report Key: 3967318
• MDR Text Key: 4630674
• Report Number: 3003898360-2014-00405
• 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: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 544230
• Device Lot Number: 01B1400542
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/06/2014
• Date Manufacturer Received: 06/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1