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

Model Number	IPN915182
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).The device history review for the product hemolok ml clips 6/cart 84/box lot# 73k2200590 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 or Problem Description
Reported issue: four clips out of six fell from the applier at loading during a surgery.The user opened a new cartridge, by which completed the surgery without problem.No clip fell/remained in the patient.
Additional Manufacturer Narrative
(b)(4).The customer returned one cartridge with two intact clips 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 slight scrape marks on the returned cartridge.The sample appeared used as there was biological material on the cartridge.No other defects or anomalies were discovered.Functional inspection was performed on the two intact clips returned in the cartridge.A lab inventory applier was used.Both clips were manually loaded into the jaws of the applier and were successfully applied to over-stressed surgical tubing without breaking or falling out of the applier.No functional issues were found with the returned clips.Per dhr the product hemolok ml clips 6/cart 84/box lot# 73k2200590 was manufactured on 10/19/2022 a total of (b)(4) pieces.Lot was released on 11/10/2022.Dhr investigation did not show issues related to complaint.The ifu for this product, l02425 rev.02, was reviewed as a part of this complaint i nvestigation.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 reported complaint of "loaded clip is insecurely seated" was not confirmed based upon the samples received.Upon functional inspection, both clips were able to properly load into the jaws of a lab inventory applier and were successfully applied to over-stressed surgical tubing.No damages, defects, or anomalies were observed to any of the returned clips.Because no functional issues were found with the returned clips, the reported issue could not be confirmed.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
Reported issue: four clips out of six fell from the applier at loading during a surgery.The user opened a new cartridge, by which completed the surgery without problem.No clip fell/remained in the patient.

• Brand Name: HEMOLOK ML CLIPS 6/CART 84/BOX
• Common Device Name: 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: 16616206
• Report Number: 3003898360-2023-00378
• Device Sequence Number: 11966412
• Product Code: FZP
• UDI-Device Identifier: 24026704695915
• UDI-Public: 24026704695915
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN915182
• Device Catalogue Number: 544230
• Device Lot Number: 73K2200590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2023
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown