MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK L CLIPS; HEMOCLIPS

Catalog Number 544240

Device Problems Activation, Positioning or Separation Problem (2906); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2015

Event Type  malfunction  

Event Description

Alleged event: the surgeon found that the slip cannot be ligated closely.Based on add'l info, the vessel did not continue to blood, the clip did not slip off the vessel; it was the "feel" of the closure that prompted the complaint.The pt's condition was reported as fine.

Manufacturer Narrative

(b)(4).The device history for the product hemolok l clips 6/cart 84/box, lot #01m1300345 investigations did not show issues related to the complaint.The device sample has not been returned to the mfr for investigation at the time of this report.The mfr will continue to monitor and trend related events.

• Brand Name: HEMOLOK L CLIPS
• Type of Device: HEMOCLIPS
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate, b.c. 2147 8; MX 21478
• Manufacturer Contact: effie jefferson, regulatory aff ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 4749226
• MDR Text Key: 5824547
• Report Number: 3003898360-2015-00327
• Device Sequence Number: 1
• Product Code: MCH
• Combination Product (y/n): N
• Reporter Country Code: CN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/20/2018
• Device Catalogue Number: 544240
• Device Lot Number: 01M1300345
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1