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

Catalog Number	544995
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported " the product was not preforming as desired".Additional information states " the device was misaligned, and he jaws were not working".No patient involvement reported.This issue happened prior to use.
Additional Manufacturer Narrative
(b)(4).The sample was not returned to the manufacturer for evaluation.The manufacturer reported:" per customer provided information the dhr for the alleged defective instrument was reviewed and found complete without any irregularities.This instrument was produced at the tecomet, inc.Kenosha, wi facility as part of a 50-pc.Lot in april of 2022.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.This instrument has not been returned for review or evaluation therefore we are unable to determine what may have caused the alleged defect or validate the alleged complaint.All 50 instruments from this lot were properly lubricated and 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." teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported " the product was not preforming as desired".Additional information states " the device was misaligned, and he jaws were not working".No patient involvement reported.This issue happened prior to use.
Additional Manufacturer Narrative
(b)(4).Per customer provided information the dhr for the alleged defective medical device was reviewed and found complete without any irregularities.The alleged defective instrument was produced at the tecomet, inc.Kenosha, wl facility as part of a (b)(4) pc.Lot in march of 2022 from lot 06a2244770.It was found that this order was made from the correct materials and components, and all approved processes were followed.A visual and functional inspection was conducted, and it was found that the jaws were dislodged from the drive rod making the jaws unable to open and close.It was also found that the knob was detached from the handle causing the knob and shaft to spin continuously.We are unable to determine what might have caused the drive rod to dislodge from the jaws and the knob to detach from the handle, but improper disassembly and mishandling of the device happened at end user's facility is suspected.All (b)(4) 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.
Event or Problem Description
It was reported " the product was not preforming as desired".Additional information states " the device was misaligned, and he jaws were not working".No patient involvement reported.This issue happened prior to use.

• Brand Name: HOL L 10MM 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19320168
• Report Number: 3011137372-2024-00077
• Device Sequence Number: 7659658
• Product Code: GDO
• UDI-Device Identifier: 34026704623649
• UDI-Public: 34026704623649
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2024

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
• Device Catalogue Number: 544995
• Device Lot Number: 06A2244770
• 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: 05/14/2024
• Supplement Date Received by Manufacturer: 06/07/2024; 04/29/2025
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 06/07/2024; 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown