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 12/10/2021

Event Type  malfunction  

Event Description

A clip got broken at loading during preparation for a surgery.The other 5 clips in the cartridge were loaded without a problem.

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

A clip got broken at loading during preparation for a surgery.The other 5 clips in the cartridge were loaded without a problem.

Manufacturer Narrative

Qn#(b)(4).Per dhr the product hemolok ml clips 6/cart 84/box lot# 73g2100140 was manufactured on 07/05/2021 a total of (b)(4) pieces.Lot was released on 07/21/2021.Dhr investigation did not show issues related to complaint.From the pictures attached it was confirmed the defect reported by the customer "broken parts - clip - info not provided".However it is necessary to receive the physical sample to perform a proper investigation, determine root cause & implement corrective actions.P/n 544230 is not being manufactured currently, however, another part number from the same family was use for the "verification of failure mode reported in the current manufacturing process" and was conducted as follows: 125 samples were taken from the current production p/n 544240 hemolok l clips 6/cart 84/box lot # 73l2101091, the samples were visually inspected, and during the test issue reported "broken parts - clip - info not provided" was not observed in the current manufacturing process.Revision of fmea-08-025 rev 05 was performed and the failure mode is already including it, no update is required.Failure mode "broken parts - clip - info not provided" could be confirmed with picture attached, however it is necessary to receive the physical sample to perform a proper investigation, determine root cause & implement corrective actions.

Manufacturer Narrative

(b)(4).The customer returned one cartridge 544230 hemolok ml clips 6/cart 84/box for investigation.The clip cartridge was visually examined with and without magnification.Visual examination revealed that the cartridge was returned with one broken clip half.The clip half was a pierced boss half that was broken in half at the hinge.The sample appears used as biological material was present on the device.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 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.".A clip was returned broken in half at the hinge during loading.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.The cartridge was returned with half of a broken clip that was broken in half at the hinge during loading.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 Description

A clip got broken at loading during preparation for a surgery.The other 5 clips in the cartridge were loaded without a problem.

• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 12983984
• MDR Text Key: 282111507
• Report Number: 3003898360-2021-01122
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 24026704695915
• UDI-Public: 24026704695915
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2021

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
• Device Operator: Health Professional
• Device Model Number: IPN915182
• Device Catalogue Number: 544230
• Device Lot Number: 73G2100140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2021
• Initial Date FDA Received: 12/13/2021
• Supplement Dates Manufacturer Received: 12/15/2021; 02/01/2022
• Supplement Dates FDA Received: 01/13/2022; 02/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2021
• 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