MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL L ENDO APPLIER 10MM 45CM; APPLIER, SURGICAL, CLIP

Model Number	IPN915198
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reported issue: during a robotic prostatectomy the applier had been used more than ten times.On the last clip needed the jaw opened wider than the clip it would not close around the vessel.The screw was missing, handle came off, the screw was found on the surgeon's gown as he was sitting down at the time.
Additional Manufacturer Narrative
Qn#(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Additional Manufacturer Narrative
Qn# (b)(4).The dhr for the returned instrument was reviewed and found complete without any irregularities.This instrument was produced at the tecomet, inc.Kenosha, wi facility as part of a 25-pc.Lot in august of 2018.It was found that this order was made from the correct materials and components and all approved processes were followed.It can then be stated that the alleged non-conformance inciting this complaint was not due to an error in tecomet - kenosha's manufacturing process.Evaluation of the returned instrument shows that the distal handle (g00388) is loose from the instrument and shoulder screw (n00186) is missing and wasn't returned with the instrument.We are able to validate this complaint.Evaluation of the tapped side of the proximal handle (g00436m) shows that the handle was properly staked in 3 places during its manufacture.We are unable to determine what caused the screw to become loose and missing and for the handle to be loose from this instrument but mishandling and lack of proper maintenance at the end user's facility is suspected.All 25 instruments from this lot were 100% visually inspected and function tested prior to shipment to the customer as this is a standardized procedure at this facility for this product line.Due to these findings, no further actions will be taken in res ponse to this complaint and this record will be deemed closed.
Event or Problem Description
Reported issue: during a robotic prostatectomy the applier had been used more than ten times; on the last clip needed the jaw opened wider than the clip it would not close around the vessel.The screw was missing, handle came off, the screw was found on the surgeon's gown as he was sitting down at the time.

• Brand Name: HOL L ENDO APPLIER 10MM 45CM
• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16628718
• Report Number: 3011137372-2023-00076
• Device Sequence Number: 5334642
• Product Code: GDO
• UDI-Device Identifier: 24026704697896
• UDI-Public: 24026704697896
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 03/01/2023

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: IPN915198
• Device Catalogue Number: 544995L
• Device Lot Number: 06A1863190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2018
• 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.; NONE REPORTED.
• Patient Sex: Unknown