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

Model Number	IPN915182
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reported event: during a robotic surgery the doctor has encountered the difficulty releasing the clip in situ because it presents an excrescence that blocks the release from the instrument, both robotic and laproscopic.He had to help with an additional robotic arm to free the stuck clips.It was reported that subsequent clip application was successful and there was no patient harm.
Additional Manufacturer Narrative
(b)(4).The device history review for the product hemolok ml clips 6/cart 84/box lot# 73f2200953 investigation did not show issues related to the complaint.From the pictures provided it was not possible to confirm the failure mode reported as difficulty loading clip into applier.It is necessary to receive the physical sample to perform a proper investigation, determine root cause and implement corrective actions.If the complaint samples become available at a later date, this complaint will be updated accordingly.Teleflex will continue to monitor and trend related events.

• 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16380324
• Report Number: 3003898360-2023-00224
• Device Sequence Number: 12343966
• Product Code: FZP
• UDI-Device Identifier: 24026704695915
• UDI-Public: 24026704695915
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 01/24/2023

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: 73F2200953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2022
• 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.
• Patient Sex: Unknown