MAUDE Adverse Event Report: TELEFLEX MEDICAL HEM-O-LOK XL ENDO 10, APPLIER; APPLIER, SURGICAL, CLIP

Model Number	IPN915193
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (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 the jaws of the applier were found misaligned before use.Therefore, a new unit was used instead.
Event or Problem Description
It was reported that the jaws of the applier were found misaligned before use.Therefore, a new unit was used instead.
Additional Manufacturer Narrative
(b)(4).The device history for the returned instrument was reviewed and found complete without any irregularities.The instrument was produced at the tecomet, inc.Kenosha, wi facility as part of a 50-pc lot in (b)(6) 2021.It was found that this order was made from the correct materials and components and all approved processes were followed.Evaluation of the returned instrument shows that the jaw opens and closes smoothly when the handle to jaw mechanism is actuated.We are unable to validate this complaint.Further shows that this instrument is able to pick-up, retain, close, and release multiple clips both with and without the use of silastic test tubing as required of its function.After the evaluation this instrument was dis-assembled to evaluate its internal components and no damage was found to any of its internal or external components.We are unable to validate this complaint since we were unable to find any non-conforming features on the returned device.All 50 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: HEM-O-LOK XL ENDO 10, 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: 15865129
• Report Number: 3011137372-2022-00231
• Device Sequence Number: 6910011
• Product Code: GDO
• UDI-Device Identifier: 24026704696820
• UDI-Public: 24026704696820
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2022

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: IPN915193
• Device Catalogue Number: 544990
• Device Lot Number: 06G2003397
• 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: 11/07/2022
• Supplement Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 11/25/2022
• Supplement Report FDA Received Date: 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown