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

Catalog Number 544230

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.The device history review for the product hemolok ml clips 6/cart 84/box 84/box lot# 73l1900069 investigation did not show issues related to complaint.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that a clip got broken when the user attempted to load it to the applier during a surgery.Therefore, he/she opened a new cartridge.

Manufacturer Narrative

Qn# (b)(4).The customer returned one cartridge 544230 hemolok ml clips 6/cart 84/box for investigation.The cartridge contained 4 intact clips and 1 broken clip.One intact clip was also returned loose.The cartridge and loose clip were visually examined with and without magnification.Visual examination revealed that the broken clip in the cartridge exhibited a staggered break where the outer hinge was broken in the center and the inner hinge was broken towards the hook side.The sample appears used as there was biological material found on the cartridge.Functional inspection was performed on the 4 intact clips from the cartridge and the 1 intact clip that was returned loose.A lab inventory clip applier was used to test the clips.The first clip was able to properly load into the applier.The clip properly fired and released onto over-stressed surgical tubing.No defects or anomalies were observed with the clip.These actions were repeated with the 4 remaining clips and the same results were found.The root cause of the staggered break at the hinge is due to inadequate specifications for insert mismatch in the highest stress area of the hinge, which is a design related issue.A capa has been previously opened to further investigate issues related to clip breakages.The ifu for this product, l02425, 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 broken clip exhibited a staggered break where it was broken at the center of the outer hinge and on the hook side of the inner hinge.The root cause is due to inadequate specifications for insert mismatch in the highest stress area of the hinge, which is a design related issue.A capa has been previously opened to further investigate issues related to clip breakages.The reported complaint of "broken parts - clip - hinge" was confirmed based upon the sample received.One cartridge was returned with 4 intact clips and 1 broken clip.There was also 1 intact clip returned loose.The broken clip exhibited a staggered break at the hinge where the outer hinge was broken at the center and the inner hinge was broken towards the hook side.The 5 intact clips that were returned were all properly able to load and fire from a lab inventory clip applier onto over-stressed surgical tubing.There were no defects or anomalies observed with the intact clips.The root cause of the staggered break at the hinge is due to inadequate specifications for insert mismatch in the highest stress area of the hinge, which is a design related issue.A capa has been previously opened to further investigate issues related to clip breakages.

Event Description

It was reported that a clip got broken when the user attempted to load it to the applier during a surgery.Therefore, he/she opened a new cartridge.

• Brand Name: HEMOLOK ML CLIPS 6/CART 84/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 10792914
• MDR Text Key: 214810404
• Report Number: 3003898360-2020-00879
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

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 Catalogue Number: 544230
• Device Lot Number: 73L1900069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/05/2020
• Supplement Dates Manufacturer Received: 12/04/2020
• Supplement Dates FDA Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1