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	09/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.
Event or Problem Description
It was reported that "the first clip came out in a closed condition during a laparoscopic right hemicolectomy.The second clip and after were loaded properly, but the user replaced the auto endo to a new one to complete the procedure.No clip fell/remained in the patient and no injury to the patient occurred".
Event or Problem Description
It was reported that "the first clip came out in a closed condition during a laparoscopic right hemicolectomy.The second clip and after were loaded properly, but the user replaced the auto endo to a new one to complete the procedure.No clip fell/remained in the patient and no injury to the patient occurred".
Additional Manufacturer Narrative
(b)(4).The customer returned one unopen representative unit of ae05ml auto endo5 ml lot#: 73l2400225 for investigation.The serial number of the device is sn: (b)(6).The returned sample was visually examined without magnification.It was observed that there were no defects on the jaws.There were no visual defects observed on the applier and the device appeared to be assembled correctly.The returned sample had no biological material present on the device.The reported complaint of "clip(s) not opening" could be confirmed based upon the representative sample received.The customer returned one unopened unit of ae05ml auto endo5 ml for investigation.Upon functional inspection, the trigger was engaged to load the clips.The first clip was observed to have a rebound failure and misfired.The remaining 14 clips were correctly loaded into the jaws and were able to fully latch.No functional problem was found with the returned sample.The ifu states, "if a clip does not load with the clip bosses nested in the jaws as shown, extracorporeally remove the clip from the jaws, and fully compress the trigger to reset the device.If three misloads occur, discard the device and replace with a new ae05ml." it was concluded that the device functions in accordance with the ifu as only one clip was misloaded.Corrective action is not required at this time, as there were no functional issues found with the returned sample.A device history record review was performed on the device with no evidence to suggest a manufacturing related root cause.There were no functional issues found with the returned applier.Teleflex will continue to monitor and trend on complaints of this nature.

• 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: 23392999
• Report Number: 3003898360-2025-00784
• Device Sequence Number: 10015205
• Product Code: FZP
• UDI-Device Identifier: 14026704553126
• UDI-Public: (01)14026704553126(11)241107(17)260507(10)73L2400225(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): 09/30/2025

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: 05/07/2026
• Device Catalogue Number: AE05ML
• Device Lot Number: 73L2400225
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown