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 Information (3190)

Event Date 12/11/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product hemolok ml clips 6/cart 84/box lot# 73l1800479 investigation did not show issues related to the complaint.Teleflex will continue to monitor and trend related events.

Event Description

The clip broke into two pieces when the doctor performing vessel or tissue ligation.Also the clip broke in the cartridge.

Manufacturer Narrative

Qn#(b)(4).The customer returned one cartridge 544230 hemolok ml clips 6/cart 84/box for investigation.The sample is for tc 1900074152 & tc 1900074153.The cartridge was returned with its original packaging and lid stock.The cartridge was visually examined with and without magnification.Visual examination of the cartridge revealed that the cartridge was returned with two broken clips and no intact clips remaining.The clips appear used as there is biological material present on the clips and the cartridge.The two broken clips were removed from the cartridge for further visual examination.One of the clips was broken in half at the hinge.However, only the hook side of the clip was returned.The pierced boss side of the clip was not returned.The other clip exhibited a staggered break where it was broken in the middle of the inner hinge and also broken on one side of the outer hinge span.The clips breaking at the hinge was determined to be the result of inadequate cross-sectional area at the outer hinge.The root cause is due to inadequate specification of hinge thickness, which is a design related issue.A capa has been previously opened to further investigate issues related to clip breakages.Reference file anp1900074152 for investigation photos.The ifu for this product, l06110, was reviewed as a part of this complaint investigation.The ifu states the following: "to load the applier, grasp the applier and carefully insert the jaws of the applier into the cartridge slot, making sure the jaws are perperndicular to the base of the cartridge.Gently press the applier over the clip until there is an audible click.Do not force the applier into the cartridge or onto the clip.The applier should enter and withdraw from the cartridge easily." "remove the applier from the cartridge ensuring the clip is held securely in the applier jaws.It may be necessary to hold the cartridge to allow the clip to be removed." "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." two clips were returned broken at the hinge.The root cause is due to inadequate specification of hinge thickness, 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/detached parts - clip - hinge" was confirmed based upon the sample received.One cartridge was returned with two broken clips and no intact clips remaining.One of the clips was broken in half at the hinge.The other clip exhibited a staggered break where it was broken in the middle of the inner hinge and also broken on one side of the outer hinge span.The clips breaking at the hinge was determined to be the result of inadequate cross-sectional area at the outer hinge.The root cause is due to inadequate specification of hinge thickness, which is a design related issue.A capa has been previously opened to further investigate issues related to clip breakages.

Event Description

The clip broke into two pieces when the doctor performing vessel or tissue ligation.Also the clip broke in the 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: 9495696
• MDR Text Key: 173230082
• Report Number: 3003898360-2019-01543
• 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: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2023
• Device Catalogue Number: 544230
• Device Lot Number: 73L1800479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Date Manufacturer Received: 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1