MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL ML 5MM ENDO APPLIER; APPLIER, SURGICAL, CLIP

Model Number	IPN921609
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "when closing the applier with a clip loaded, the closure system (applier's head) separated, making it impossible to apply the clip.It was impossible to remove the applier from the trocar, so the surgeon had to remove the trocar with the applier still inside and insert a new trocar.The clip remained in the jaws of the applier".No report of patient harm or injury.
Additional Manufacturer Narrative
Qn# (b)(4).The sample was returned to the manufacturer for evaluation.The manufacturer reported: "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 april of 2024 from lot number 06g2361678.The investigation determined that the manufacturing processes adhered to approved specifications, utilizing the correct materials and components.A comprehensive visual and functional inspection was performed to determine the cause of the applier head separation.The investigation revealed that the rivet had dislodged, leading to detachment of the jaws from the outer tube.This misalignment compromised the device's ability to properly load and close the clip, ultimately rendering it nonfunctional.While the exact cause of the misalignment and rivet dislodgement could not be conclusively identified, excessive force during use at the end user's facility is suspected.Notably, all 50 instruments from this lot underwent 100% visual inspection and functional testing prior to shipment, in accordance with standard operating procedures 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 on complaints of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "when closing the applier with a clip loaded, the closure system (applier's head) separated, making it impossible to apply the clip.It was impossible to remove the applier from the trocar, so the surgeon had to remove the trocar with the applier still inside and insert a new trocar.The clip remained in the jaws of the applier".No report of patient harm or injury.

• Brand Name: HOL ML 5MM ENDO APPLIER
• Common Device Name: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22509812
• Report Number: 3003898360-2025-00580
• Device Sequence Number: 9246634
• Product Code: GDO
• UDI-Device Identifier: 34026704623625
• UDI-Public: (01)34026704623625(11)240503(17)001231(10)06G2361678(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2025

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: IPN921609
• Device Catalogue Number: 544965
• Device Lot Number: 06G2361678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown