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

Model Number	IPN915191
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2022
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 during a surgery, a clip got broken at ligation, another clip was not loaded to the applier properly, and the other clip got broken at the hinge at loading.The user managed to complete the surgery with the applier.The fragment of the clip fell in the patient, but all of them were removed and discarded.No patient injury occurred.The user made an inquiry to us that the clips might have been defective first, but when our sales representative visited the hospital and checked the applier, he found that the jaws were slightly deformed.
Additional Manufacturer Narrative
(b)(4).The instrument with lot w1-01 was shipped to tfx with invoice (b)(4) of 22/11/21.Original manufacturing lot is 22142129, 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 dimensional check did not reveal any deviating dimensions.Clips were picked up and applied without any problems, and the visual inspection showed no evidence of a bent jaw.A bent pull wire was detected, which had no effect on the pick-up and application of clips.The instrument is working properly and is not the cause of the error.Possible causes are user errors, as indicated by the bent pull wire due to strong force, or faulty clips.No further measures will be initiated by (b)(4); this complaint is being rejected by us.
Event or Problem Description
It was reported that during a surgery, a clip got broken at ligation, another clip was not loaded to the applier properly, and the other clip got broken at the hinge at loading.The user managed to complete the surgery with the applier.The fragment of the clip fell in the patient, but all of them were removed and discarded.No patient injury occurred.The user made an inquiry to us that the clips might have been defective first, but when our sales representative visited the hospital and checked the applier, he found that the jaws were slightly deformed.

• 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: 16095799
• Report Number: 3011137372-2023-00003
• Device Sequence Number: 15116166
• 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
• Report Date (Section B): 12/16/2022

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
• Operator of Device: Health Professional
• Device Model Number: IPN915191
• Device Catalogue Number: 544965T
• Device Lot Number: W1-01
• 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: 12/16/2022
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2021
• 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
• Patient Sex: Unknown