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

Catalog Number 544240

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/28/2015

Event Type  malfunction  

Event Description

Alleged event: during a cholecystectomy, the doctor found clip cannot be closed during use.He changed to another lot to complete the surgery.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).The device history review for the product hemolok l clips 6/cart 84/box, lot # 73d1400710 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) single clip of catalog number 544240 hemolok l clips 6/cart 84/box was received used, and not in original packaging, lot # was not confirmed.During visual inspection it was observed that the clip received was open (clip was observed in good condition: no damage), however clip is painted; root cause is unknown.Functional inspection: one hem-o-lok clip was placed manually on applier p/n 544180, batch # 06l0915814; the clip was loaded properly / correctly into the clip applier, and no quality issues were found.A closure test was performed on the clip, and no quality issues were found.Sample received did not confirm the defect reported by the customer "not closing" during visual inspection.A functional inspection was performed with remaining clip, the device worked properly.Therefore, a corrective action is not required at this time.In addition, one only clip was received for evaluation.However, we will continue monitor trending of similar complaints.

Event Description

Alleged event: during a cholecystectomy the doctor found clip cannot be closed during use.He changed to another lot to complete the surgery.The patient's condition was reported as fine.

• Brand Name: HEMOLOK L CLIPS
• Type of Device: HEMOLOK CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 2147 8; MX 21478
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 4862997
• MDR Text Key: 5866966
• Report Number: 3003898360-2015-00480
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 544240
• Device Lot Number: 73D1400710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2014
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1