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	09/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the clip got stuck in the applier and did not come out of the shaft (not loaded) during use.It occurred 3 times (3 clips jammed), but the other clips were loaded properly, so the autoendo was used as it was to complete the procedure.No clip fell/remained in the patient and no injury to the patient occurred".
Additional Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
(b)(4).The customer returned two unopened representative units of ae05ml auto endo5 ml for investigation.The serial number for the samples were (b)(6), the lot number for each sample was 73d2500116.The returned devices were examined without a microscope.No damage was observed on the packaging or on the device for either sample.The reported complaint of "jamming - clip stuck in jaw area" could not be confirmed based upon the samples received.The customer returned two representative samples, each unopened in their packaging.The samples were visually inspected, and no damage was observed on the packaging or devices.Functional inspection was performed on the samples.For sample 1, the device was removed from the packaging and inspected.The safety pin was then removed from the device with no issues.The trigger was actuated and the clip properly loaded into the jaws and latched.The trigger was engaged again and the clip properly loaded into the jaws and latched.The remaining clips were able to load into the jaws and latch with no issues.No clips were observed getting stuck in the jaw area.15 clips were remaining in the device.For sample 2, the device was removed from the packaging and inspected.The safety pin was then removed from the device with no issues.The trigger was actuated and the clip properly loaded into the jaws and latched.The trigger was engaged again and the clip properly loaded into the jaws and latched.The remaining clips were able to load into the jaws and latch with no issues.No clips were observed getting stuck in the jaw area.15 clips were remaining in the device.No functional problems were found with the returned samples.The probable cause of this complaint issue could not be determined based upon the information provided and without the actual sample.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 "the clip got stuck in the applier and did not come out of the shaft (not loaded) during use.It occurred 3 times (3 clips jammed), but the other clips were loaded properly, so the auto endo was used as it was to complete the procedure.No clip fell/remained in the patient and no injury to the patient occurred".

• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23149100
• Report Number: 3003898360-2025-00737
• Device Sequence Number: 21319271
• Product Code: FZP
• UDI-Device Identifier: 14026704553126
• UDI-Public: (01)14026704553126(11)250406(17)261004(10)73D2500116(21)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• 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: 10/04/2026
• Device Catalogue Number: AE05ML
• Device Lot Number: 73D2500116
• 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: 11/11/2025
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2025
• 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