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

Model Number IPN915182

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product hemolok ml clips 6/cart 84/box lot# 73f2200473 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

Reported issue: (b)(6) 2022, clip was found broken when clipped by applier.No patient involvement.

Manufacturer Narrative

(b)(4) the customer one cartridge from one unit of 544230 hemolok ml clips 6/cart 84/box for investigation.The returned sample was visually examined with and without magnification.Visual examination revealed evidence of small scratches on the cartridge and three broken clips were broken in half at the hinge.A total of three pierced boss halves and three hook halves were returned.Biological material was observed on the returned sample.The clips breaking at the hinge during loading was determined to be the result of insert mismatch at the hinge area of the clip.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.Functional inspection was conducted on the three remaining clips in the cartridge.A lab inventory clip applier was used.All three clips in the cartridge were able to properly load into the jaws of the applier and were successfully applied to over-stressed surgical tubing.No clips broke during testing.No functional issues were found with the returned clips.The device history review for the product hemolok ml clips 6/cart 84/box lot# 73f2200473 investigation did not show issues related to the complaint.The ifu for this product, l02425 rev.02, 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 broken clips were broken at the hinge during loading.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.The reported complaint of broken/detached parts - clip - hinge was confirmed based upon the sample received.Three broken clips returned, and all were broken in half at the hinge.The three remaining clips were tested and functioned properly upon application.The clips breaking at the hinge during loading was determined to be the result of insert mismatch at the hinge area on the pierce leg side of the hinge.The root cause is due to inadequate specifications for insert mismatch in the highest stress area of the hinge, which is a design r elated issue.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

Reported issue: (b)(6) 2022, clip was found broken when clipped by applier.No patient involvement.

• Brand Name: HEMOLOK ML CLIPS 6/CART 84/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16121291
• MDR Text Key: 306909548
• Report Number: 3003898360-2023-00070
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 24026704695915
• UDI-Public: 24026704695915
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K133202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/22/2022

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 Model Number: IPN915182
• Device Catalogue Number: 544230
• Device Lot Number: 73F2200473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2022
• Initial Date FDA Received: 01/09/2023
• Supplement Dates Manufacturer Received: 02/02/2023
• Supplement Dates FDA Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED