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

Model Number	IPN028126
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).The device history review could not be conducted since the lot number was not provided.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
It was reported that 2 clips got broken at the hook when they were loaded during a surgery.Therefore, a new unit was opened instead.
Additional Manufacturer Narrative
(b)(4).Although the lot number was not reported, a potential lot number was obtained through the sales history.The potential lot number is 73a2000103.Per dhr the product hemolok ml clips 6/cart 84/box lot# 73a2000103 was manufactured on 01/08/2020 a total of 14,994 pieces.Lot was released on 01/22/2020.Dhr investigation did not show issues related to complaint.The customer returned one cartridge 544230 hemolok ml clips 6/cart 84/box for investigation.This is 1 of 2 tcs opened for the same complaint issue (2 total cartridges).Refer to tc 1900082190 for investigation on the second cartridge returned by the customer.The cartridge was returned with no clips remaining.There were also 5 loose clips returned.Four of the returned clips were intact and one was broken at the hinge.The sample was visually examined with and without magnification.Visual examination revealed that the broken clip was broken in half at the hinge.The sample appeared used as there was biological material present on the clips and cartridge.Functional inspection was performed on the 4 intact clips.A lab inventory clip appier was used and all 4 clips were able to be manually loaded into the jaws of the applier.Each clip was successfully able to fire onto over-stressed surgical tubing.No defects or anomalies were observed with the intact clips.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.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 loose 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 parts - clip - hinge" was confirmed based upon the sample received.One cartridge was returned empty with 5 clips that were returned loose.Four of these clips were intact clips that were all able to successfully load into lab inventory clip appliers and fire onto over-stressed surgical tubing.One of the clips was returned 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.
Event or Problem Description
It was reported that 2 clips got broken at the hook when they were loaded during a surgery.Therefore, a new unit was opened instead.

• Brand Name: HEMOLOK ML CLIPS 6/CART 84/BOX
• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11278752
• Report Number: 3003898360-2021-00059
• Device Sequence Number: 3711765
• Product Code: FZP
• UDI-Device Identifier: 34026704625193
• UDI-Public: 34026704625193
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2021

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
• Operator of Device: Health Professional
• Device Model Number: IPN028126
• Device Catalogue Number: 544230
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 02/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1