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

Catalog Number 544240

Device Problem Unintended Ejection (1234)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device investigation is pending.The device history review for the product hemolok l clips 6/cart 84/box lot# 73f1700191 investigation did not show issues related to the complaint.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the clips were falling.

Event Description

It was reported that the clips were falling.

Manufacturer Narrative

Qn#(b)(4).The customer returned one cartridge 544240 hemolok l clips 6/cart 84/box for investigation.Four loose clips were also returned.The cartridge was returned with its original packaging and lid stock but no clips were remaining in it.The clip cartridge and loose clips were visually examined with and without magnification.Visual examination revealed that the loose clips appear used as there is biological material present on the clips.Scrape marks were observed near the pierced bosses on two of the clips.The other two clips had scrape marks near the pierced bosses but also had divots near the hook.One of the clips with the divots near the hook also had a piece of the clip that seemed to be separating from the rest of the clip.The damages observed on the clips appear to be consistent with damage that may be caused by improper loading or use of damaged appliers.However, this could not be confirmed since the appliers were not returned.Functional inspection was performed on the returned clips.A lab inventory clip applier was used.The clips were manually loaded into the jaws of the applier.The clips were able to properly load into the jaws of the applier and were successfully applied to over-stressed surgical 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 "clip fell from applier" could not be confirmed based upon the sample received.Upon functional inspection, the returned clips were able to properly load into the jaws of the lab inventory applier and were successfully applied to over-stressed surgical tubing.Since no functional issues were found with the returned clips and the applier was not returned, the reported issue could not be confirmed.

• Brand Name: HEMOLOK L CLIPS 6/CART 84/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8355371
• MDR Text Key: 136782675
• Report Number: 3003898360-2019-00254
• 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: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/06/2022
• Device Catalogue Number: 544240
• Device Lot Number: 73F1700191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Initial Date Manufacturer Received: 01/28/2019
• Initial Date FDA Received: 02/20/2019
• Supplement Dates Manufacturer Received: 03/07/2019
• Supplement Dates FDA Received: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1