MAUDE Adverse Event Report: TELEFLEX MEDICAL AUTO ENDO5 ML; CLIP, IMPLANTABLE

Catalog Number	AE05ML
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn #: (b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "applier would not load any clips, like it was jammed".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Upon further review of the investigation report, it was determined that this was not a reportable event; thus the initial mdr submitted on 25-september-2025 and the follow-up sent on 30-october-2025 should be retracted.The customer returned one unit of ae05ml auto endo5 ml for investigation.The returned sample was visually examined with and without magnification.Visual examination of the returned sample revealed a broken safety pin in the safety pin hole.The hole where the safety pin is placed was deformed on the applier's handle frame.There was no biological material observed on the device.The reported complaint of "broken safety pin" was confirmed based upon the sample received.The device was returned with a broken safety pin and damaged the safety pin hole.Proper functional testing could not be completed because the applier was unable to be engaged due to the broken safety pin.R & d concluded the probable root cause for the safety pin breakage is a fracture defect with the supplied safety pins.Actions to address the safety pin break were established as part of a non-conformance, which was closed on 29-jul-2025.The returned sample was manufactured prior to these actions on 23-mar-2025.A device history record review was performed, and no relevant findings were identified.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 "applier would not load any clips, like it was jammed".No patient harm or injury.The patient status is reported as "fine".
Event or Problem Description
It was reported that "applier would not load any clips, like it was jammed".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4): the customer returned one unit of ae05ml auto endo5 ml for investigation.The returned sample was visually examined with and without magnification.Visual examination of the returned sample revealed a broken safety pin in the safety pin hole.The hole where the safety pin is placed was deformed on the applier's handle frame.There was no biological material observed on the device.The reported complaint of "broken safety pin" was confirmed based upon the sample received.The device was returned with a broken safety pin and damaged the safety pin hole.Proper functional testing could not be completed because the applier was unable to be engaged due to the broken safety pin.R & d concluded the probable root cause for the safety pin breakage is a fracture defect with the supplied safety pins.Actions to address the safety pin break were established as part of a non-conformance, which was closed on 29-jul-2025.The returned sample was manufactured prior to these actions on 23-mar-2025.A device history record review was performed, and no relevant findings were identified.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a.Corrected data: n/a.

• Brand Name: AUTO ENDO5 ML
• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: laura guadalupe gonzalez ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23148893
• Report Number: 3003898360-2025-00747
• Device Sequence Number: 9909736
• Product Code: FZP
• UDI-Device Identifier: 14026704553126
• UDI-Public: (01)14026704553126(11)250323(17)260920(10)73C2500720(21)
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K230480
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2025

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 Expiration Date: 09/20/2026
• Device Catalogue Number: AE05ML
• Device Lot Number: 73C2500720
• 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: 09/09/2025
• Supplement Date Received by Manufacturer: 10/21/2025; Not provided
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 10/30/2025; 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2025
• 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