MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK ML CLIPS 6/CART 84/BOX; CLIP, IMPLANTABLE

Model Number IPN915182

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2022

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the device did not work as intended, hem-o-lok's are snapping during intended action in the abdomen.The patient's condition was reported as unknown.

Event Description

It was reported that the device did not work as intended, hem-o-lok's are snapping during intended action in the abdomen.The patient's condition was reported as unknown.

Manufacturer Narrative

Qn# (b)(4).The customer returned one cartridge 544230 hemolok ml clips 6/cart 84/box for investigation.The clip cartridge was visually examined with and without magnification.Visual examination of the returned cartridge revealed that there were 2 clips remaining in the cartridge.The lid stock was also returned.The sample appeared used as there was biological material present on the cartridge.Functional inspection was performed on the returned sample.A lab inventory clip applier was used.Both remaining clips were able to properly load into the jaws of the applier and were both successfully applied to over-stressed surgical tubing.No functional issues were found with the returned clips.Per dhr the product hemolok ml clips 6/cart 84/box lot# 73m2100245 was manufactured on 12/13/2021 a total of (b)(4).Lot was released on 01/11/2022.Dhr investigation did not show issues related to complaint.The ifu for this product, l02425 rev 02, was reviewed as a part of this complaint investigation.The ifu states, "always check the alignment of the applier jaws before use.When closed, jaw tips should be directly aligned and not offset.Alignment of the jaw is critical for safe application of the clip.If this is not done, patient injury may occur.Proper maintenance, care and cleaning are necessary to ensure proper functionality." the reported complaint of "broken parts - clip - info not provided" was not confirmed based upon the sample received.Upon functional inspection, both remaining clips were able to properly load into the jaws of a lab inventory applier and were both successfully applied to over-stressed surgical tubing.No damages were observed to any of the returned clips.Since no functional issues were found with the returned clips, the reported issue could not be confirmed.

• Brand Name: HEMOLOK ML CLIPS 6/CART 84/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15835131
• MDR Text Key: 306374175
• Report Number: 3003898360-2022-00747
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 24026704695915
• UDI-Public: 24026704695915
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K133202
• 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: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN915182
• Device Catalogue Number: 544230
• Device Lot Number: 200138W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2022
• Initial Date FDA Received: 11/21/2022
• Supplement Dates Manufacturer Received: 01/04/2023
• Supplement Dates FDA Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED