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

Catalog Number 544250

Device Problem Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product hemolok xl clips 6/cart 84/box lot# 73m1600313 investigation did not show issues related to the complaint.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the clip unable to ligate.No clips fell in the patient.

Manufacturer Narrative

(b)(4).The customer returned one cartridge 544250 hemolok xl clips 6/cart 84/box for investigation.The cartridge the clips were visually examined with and without magnification.Visual examination of the returned clips revealed that the clips appeared used as there is biological material present on one of the clips.Two of the loose clips were returned open and the other two clips were already closed.However, one of the closed clips was not completely closed.The applier was not returned.Reference file (b)(4) for investigation photos.Functional inspection was performed on the returned clips.A lab inventory clip applier was used.The two loose clips that were open were manually loaded into the jaws of the applier.Both clips were able to properly load into the jaws of the applier and were successfully applied to true-max tubing.Next, the two clips remaining in the cartridge were tested.Both clips were able to properly load into the jaws of the applier and were successfully applied to true-max tubing.No functional issues were found with the returned clips.The ifu for this product, l06110, 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 "unable to ligate" was not confirmed based upon the sample received.Upon functional inspection, all four clips that could be tested were able to properly load into the jaws of a lab inventory applier and were successfully applied to true-max tubing.Since no functional issues were found with the returned clips and the applier was not returned, the reported issue could not be confirmed.

Event Description

It was reported that the clip unable to ligate.No clips fell in the patient.

• Brand Name: HEMOLOK XL CLIPS 6/CART 84/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 7693781
• MDR Text Key: 114159776
• Report Number: 3003898360-2018-00523
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K133202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2021
• Device Catalogue Number: 544250
• Device Lot Number: 73M1600313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Date Manufacturer Received: 08/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1