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

Catalog Number	AE05ML
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer returned one unit of ae05ml auto endo5 ml lot # 73b2500788 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.The sample was returned with a clip correctly loaded in the jaws.There were no visual defects observed on the applier and the device appeared to be assembled correctly.The device was returned with the trigger engaged.The returned sample had biological material present on the device.Upon functional inspection, the trigger was engaged to load the clips.The sample was returned with a clip correctly loaded in the jaws.Upon functional inspection, the trigger was fully engaging and the first clip correctly latched.The remaining 2 clips were correctly loaded into the jaws and were able to fully latch.The jaws were observed to fully open when loading the clips.No defects were observed on the jaws.No functional problem was found with the returned sample.It was concluded that the device functions in accordance with the ifu.The device was returned with 3 clips remaining in the channel, indicating 12 clips were fired by the end user.Per dhr the product auto endo5 ml lot # 73b2500788 was manufactured on 03/01/2025 a total of (b)(4) pieces.Lot was released on 03/07/2025.Dhr investigation did not show issues related to complaint.The ifu for this product was reviewed as a part of this complaint investigation.The ifu for this product states, "mishandling of appliers may result in improper load and/or closure of the ligating clip." and that "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." corrective action is not required at this time, as there were no functional issues found with the returned sample.The sample was able to load and fire all the remaining clips correctly.The ifu, l06072 rev 04, states "mishandling of appliers may result in improper load and/or closure of the ligating clip." it was concluded that the device functions in accordance with the ifu.The reported complaint of "clip(s) not loading properly " could not be confirmed based upon the sample received.The customer returned one unit of ae05ml auto endo5 ml for investigation.The returned applier correctly fired and latched the remaining clips.Upon functional testing, the jaws were observed to fully open to load the clips.No defects were observed on the jaws.Corrective action is not required at this time, as there were no functional issues found with the returned sample.The ifu states "mishandling of appliers may result in improper load and/or closure of the ligating clip." it was concluded that the device functions in accordance with the ifu.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.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "clips were not firing.No further information could be confirmed with the customer.".

• Brand Name: WECK 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 23877783
• Report Number: 3003898360-2025-00924
• Device Sequence Number: 4669606
• Product Code: FZP
• UDI-Device Identifier: 14026704553126
• UDI-Public: (01)14026704553126(11)250301(17)260829(10)73B2500788(21)
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Report Date (Section B): 11/26/2025

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: 08/29/2026
• Device Catalogue Number: AE05ML
• Device Lot Number: 73B2500788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2025
• 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