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 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product hemolok ml clips 6/cart 84/box lot# 73d1900257 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 a clip was found broken at opening the cartrige and could not be loaded to applier.Therefore, a new cartridge was opened instead.

Event Description

It was reported that a clip was found broken at opening the cartrige and could not be loaded to applier.Therefore, a new cartridge was opened instead.

Manufacturer Narrative

Qn#(b)(4).The customer returned one cartridge 544230 hemolok ml clips 6/cart 84/box for investigation.The cartridge was visually examined with and without magnification.Visual examination of the cartridge revealed that the cartridge was returned with a broken clip and no intact clips remaining in it.The broken clip was removed from the cartridge and it was observed that it was broken in half at the hinge.The clip breaking at the hinge during loading 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 anp1900073862 for investigation photos.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 returned clip was broken in half 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 a broken clip.The returned clip was broken in half at the hinge.The clip breaking at the hinge during loading 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.

• Brand Name: HEMOLOK ML CLIPS 6/CART 84/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9482063
• MDR Text Key: 173224272
• Report Number: 3003898360-2019-01504
• 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,u
• Type of Report: Initial,Followup
• Report Date: 12/02/2019

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 Expiration Date: 04/08/2024
• Device Catalogue Number: 544230
• Device Lot Number: 73D1900257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 01/21/2020
• Supplement Dates FDA Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1