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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "when firing the clip, it was very stiff and difficult to handle".No patient harm or injury reported.The patient's status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one unit of ae05ml auto endo5 ml lot#: 73k2400841 for investigation.The serial number of the device is sn: (b)(6).The returned sample was visually examined without magnification.The trigger was returned unengaged, and the jaws were open.It was observed that there were no defects on the jaws.There were no other visual defects observed on the applier and the device appeared to be assembled correctly.The returned sample had no evidence of biological material present on the device.Upon functional inspection, the first clip fully loaded into the jaws and was able to latch with no issues.The trigger was engaged again and the second clip loaded into the jaws and latched properly.The trigger was engaged again and the third clip properly loaded into the jaws and latched with no issues.All remaining clips were able to load and latch with no issues, and no clips were observed to get stuck in the jaws or not open.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 6 clips remaining in the channel, indicating 9 clips were fired by the end user.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 (illustration 3), 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." the sample was able to load and fire all the remaining clips correctly.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.The reported complaint of "failure to function - info not provided" could not be confirmed based upon the sample received.The customer returned one unit of ae05ml auto endo5 ml for investigation.The returned applier correct ly 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.
Event or Problem Description
It was reported that "when firing the clip, it was very stiff and difficult to handle".No patient harm or injury reported.The patient's status is reported as "fine".

• 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: azhwan barazenda ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24549159
• Report Number: 3003898360-2026-00111
• Device Sequence Number: 14868457
• Product Code: FZP
• UDI-Device Identifier: 14026704741868
• UDI-Public: (01)14026704741868(11)241024(17)260423(10)73K2400841(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,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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: 04/23/2026
• Device Catalogue Number: AE05ML
• Device Lot Number: 73K2400841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown