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	11/12/2021
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
The inner shaft was bent so that the applier could not be assembled smoothly before use.Therefore, a new unit was used instead.The applier was purchased by the hospital within 10 months.
Additional Manufacturer Narrative
(b)(4).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.During visual and functional examination , we found the following: pull rod bent/deformed very strongly as a result of too much pressure with the handle.Due to deformation of the pull rod, the applier cannot be assembled.It was determined that there was too much force to the handle during use.Therefore, no further measures will be initiated.
Event or Problem Description
The inner shaft was bent so that the applier could not be assembled smoothly before use.Therefore, a new unit was used instead.The applier was purchased by the hospital within 10 months.

• 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: 12967332
• Report Number: 3011137372-2021-00333
• Device Sequence Number: 19937353
• 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): 11/22/2021

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: J7-03
• 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: 11/22/2021
• Supplement Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 12/09/2021
• Supplement Report FDA Received Date: 03/21/2022
• 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