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 10/21/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review could not be conducted since the lot number was not provided.The device investigation is pending, and the investigation results will be submitted in a follow-up report.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the clip got broken at loading during a surgery.Therefore, a new cartridge was opened instead.Additional information: no clips fell into the patient and no other medical intervention was performed.The actual lot number could not be obtained but the potential lot 73f2200954 from the sales history.

Manufacturer Narrative

Qn#(b)(4).The customer returned one cartridge with one broken clip from one unit of 544230 hemolok ml clips 3/cart 42/box for investigation.The returned components were visually examined with and without magnification.Visual examination revealed that the loose clip was broken in half at the hinge.Small scrapes were observed on the returned cartridge.No other defects or anomalies were observed.Evidence of use in the form of biological material was observed on the returned cartridge.The clip breaking in half 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.Dimensional inspection was not required as a part of this complaint investigation.Functional inspection could not be performed due to the damage to the returned clip.The lot number was not reported, but a potential lot number was found by looking at sales history.The potential lot number is 73f2200954.Per dhr the product hemolok ml clips 6/cart 84/box lot# 73f2200954 was manufactured on 06/28/2022 a total of (b)(4) pieces.Lot was released on 07/06/2022.Dhr investigation did not show issues related to complaint.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 returned clip was 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.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.A broken clip was returned, and it was broken in half at the hinge.The clip 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 related issue.A capa has been previously opened to further investigate issues related to clip breakages.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

It was reported that the clip got broken at loading during a surgery.Therefore, a new cartridge was opened instead.Additional information: no clips fell into the patient and no other medical intervention was performed.The actual lot number could not be obtained but the potential lot 73f2200954 from the sales history.

• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15828193
• MDR Text Key: 304009639
• Report Number: 3003898360-2022-00662
• 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
• Report Date: 10/24/2022

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2022
• Initial Date FDA Received: 11/18/2022
• Supplement Dates Manufacturer Received: 12/13/2022
• Supplement Dates FDA Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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