MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK L CLIPS 6/CART 84/BOX

Catalog Number 544240

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2015

Event Type  malfunction  

Event Description

Complaint alleges that during endoscopic surgery, the surgeon found that the clip can't be closed.Patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).A device history record (dhr) review did not show issues related to complaint.Device sample has been returned to the manufacturer; however, the investigation results have not been completed at the time of the report.The manufacturer will continue to monitor and trend relating complaints.

Manufacturer Narrative

(b)(4).One (1) single clip of catalog number 544240 hemolok ml clips(b)(4) was received, lot # 73d1400546 was confirmed in the original packaging.During visual inspection, the clip received was opened (clip was observed in good condition: no damage).Failure mode not closing was not confirmed during visual inspection.A functional inspection was performed with clip received, the device works properly.No quality issues were found, the failure mode not closing reported by the customer could not be duplicated with the available sample.The manufacturer will continue to monitor and trend relating complaints.

Event Description

Complaint alleges that during endoscopic surgery, the surgeon found that the clip can't be closed.Patient's condition was reported as fine.

• Brand Name: HEMOLOK L CLIPS 6/CART 84/BOX
• Type of Device: 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: doris sturgis ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334953
• MDR Report Key: 4838117
• MDR Text Key: 5908976
• Report Number: 3003898360-2015-00378
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2015
• 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: 73D1400546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2014
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1