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

Catalog Number 544240

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2015

Event Type  malfunction  

Event Description

Alleged event: a doctor in general surgery found that the clips cannot be ligated closely and they dropped off the applier.The patient's condition was reported as fine.

Manufacturer Narrative

Qn#(b)(4).The device history review for the product hemolok l clips 6/cart 84/box, lot #01m1300261 investigation did not show issues related to the complaint.The device sample has not been returned to the manufacturer for investigation at the time of this report.The manufacturer will continue to monitor and trend related events.

Manufacturer Narrative

(b)(4).One (1) cartridge of catalog number 544240 hemolok l clips (b)(4) was received not used, closed in original packaging.The sample lot number 01l1300440 does not match the lot number of the notification 01m1300261 as reported.The failure mode not closing was not confirmed because the incorrect sample was returned.The manufacturer 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 2147 8; MX 21478
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 4661845
• MDR Text Key: 5732317
• Report Number: 3003898360-2015-00229
• Device Sequence Number: 1
• Product Code: MCH
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2018
• Device Catalogue Number: 544240
• Device Lot Number: 01M1300261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/13/2013
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1