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

Model Number	IPN915198
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device investigation is pending.
Event or Problem Description
Set screw that retains the handle came out of instrument during surgery.No patient injury or consequence.
Event or Problem Description
Set screw that retains the handle came out of instrument during surgery.No patient injury or consequence.
Additional Manufacturer Narrative
(b)(4), the dhr for the returned instrument was reviewed and found completely without any irregularities.This instrument was produced at the tecomet, inc.Kenosha, wi facility as part of a 25-piece lot in may of 2021.It was found that this order was made from the correct materials and components and all 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 instrument shows that it has additional repair lot coding on the proximal handle (g00436m) of r-11-21 signifying that this instrument has previously been sent in for repair prior to this complaint.Further evaluation shows that the distal handle (g00388) and shoulder screw (n00186) are loose and separate from the instrument thus we are able to validate this complaint.We are unable to determine what caused the distal handle and shoulder screw to be loose from the instrument but mishandling and or tampering of this device 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 response to this complaint and this record will be deemed closed.

• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 13938929
• Report Number: 3011137372-2022-00043
• Device Sequence Number: 12437946
• Product Code: GDO
• UDI-Device Identifier: 24026704697896
• UDI-Public: 24026704697896
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2022

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: IPN915198
• Device Catalogue Number: 544995L
• Device Lot Number: 06G2003415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2022
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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