MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK TAKEAPART ML 5MM ENDO APPLIER; APPLIER, SURGICAL, CLIP

Model Number	IPN915191
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
It was reported that the user was unable to load clips into applier because clips got broken at loading.Therefore, another take apart was used instead, but the same issue occurred again.There was no reported injury.
Event or Problem Description
It was reported that the user was unable to load clips into applier because clips got broken at loading.Therefore, another take apart was used instead, but the same issue occurred again.There was no reported injury.
Additional Manufacturer Narrative
(b)(4).The instrument was not sent for examination.We could not perform a functional test to reproduce and understand the problem.The instrument w/ lot o2 - 03 was shipped to teleflex with invoice #2227150 of 2022/03/15 original manufacturing lot is 22143325.Upon review of the device history records for the affected lot number, we can confirm that both the correct material and correct components had been used and that the instrument meets the product specifications.All process steps were found to have been properly documented.100% functional test at final inspection found good.The root cause could not be determined as product was not returned.No further measures will be initiated by k & w.
Additional Manufacturer Narrative
(b)(4).The complaint has already been answered with our operation number 22300013 as a complaint without an instrument present.The instrument is now available, and we have performed several clip checks.All clips could be picked up and applied without any problems.We were unable to reproduce the error described.The following shipping details were established: the instrument w/ lot o2 - 03 was shipped to tfx with invoice #2227150 of 22/03/15.Original manufacturing lot is 22143325, hr review: upon review of the device history records for the affected lot number, we can confirm that both the correct material and correct components had been used and that the instrument meets the product specifications.All process steps were found to have been properly documented.100% functional test at final inspection found good.The instrument is working properly and is not the cause of the error.Possible causes are user errors or faulty clips.No further measures will be initiated by k & w; this complaint is being rejected by us.
Event or Problem Description
It was reported that the user was unable to load clips into applier because clips got broken at loading.Therefore, another takeapart was used instead, but the same issue occurred again.There was no reported injury.
Event or Problem Description
It was reported that the user was unable to load clips into applier because clips got broken at loading.Therefore, another take apart was used instead, but the same issue occurred again.There was no reported injury.
Additional Manufacturer Narrative
Qn#(b)(4).The complaint has already been answered with our operation number (b)(4) as a complaint without an instrument present.The instrument is now available, and we have performed several clip checks.All clips could be picked up and applied without any problems.We were unable to reproduce the error described.Upon review of the device history records for the affected lot number, we can confirm that both the correct material and correct components had been used and that the instrument meets the product specifications.All process steps were found to have been properly documented with 100% functional test at final inspection found good.The instrument is working properly and is not the cause of the error.Possible causes are user errors or faulty clips.No further measures will be initiated by k & w.

• Brand Name: HEMOLOK TAKEAPART ML 5MM ENDO APPLIER
• Common Device Name: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16128071
• Report Number: 3011137372-2023-00005
• Device Sequence Number: 3238298
• Product Code: GDO
• UDI-Device Identifier: 24026704697841
• UDI-Public: 24026704697841
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup,Followup
• Report Date (Section B): 12/26/2022

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: IPN915191
• Device Catalogue Number: 544965T
• Device Lot Number: O2-03
• 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: 12/26/2022
• Supplement Date Received by Manufacturer: 01/17/2023; 02/10/2023; 02/10/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 01/18/2023; 02/15/2023; 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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; NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown