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

Model Number	IPN915191
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.
Event or Problem Description
The user could ligate without problem during the surgery.However, according to the user, when opening the handle, he/she felt loose/light, so the inner shaft came out of the outer shaft.
Event or Problem Description
The user could ligate without problem during the surgery.However, according to the user, when opening the handle, he/she felt loose/light, so the inner shaft came out of the outer shaft.
Additional Manufacturer Narrative
(b)(4).The sample was returned.During visual and functional examination, it was found that the pull rod is deformed on the distal end.The locking mechanism of the insert and the shaft is worn, so the insert easily jumps out of the locking mechanism.On the handle we found no malfunction.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.In summary, the root cause has been determined to be too much force to the handle during use and wearing at the insert.No further measures will be initiated by the manufacturer.

• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15363345
• Report Number: 3011137372-2022-00184
• Device Sequence Number: 6928082
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2022

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: K8-03
• 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: 08/25/2022
• Supplement Date Received by Manufacturer: 10/30/2022
• Initial Report FDA Received Date: 09/06/2022
• Supplement Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: N/A.
• Patient Sex: Unknown