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	11/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "during a procedure 4 clips did not load properly, the first two clips did not load properly when inserted in the patient, the doctor retracted the applier and got 4 clips to fire properly on the patient, then when we were examining the used applier after the case, we had two more clips not load properly".No patient harm or injury reported.No medical intervention required.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one unit of ae05ml auto endo5 ml for investigation.The serial number was (b)(6).The returned sample was visually examined without magnification.The trigger was returned engaged, and the jaws were closed.No defects or anomalies were observed on the device.There was evidence of biological material observed on the device.Functional testing was performed, and the trigger was engaged to reset the jaws.The trigger was fully engaged, and the ratchet sounds could be heard and the jaws mechanism functioned as intended.The indicator clip loaded into the jaws and was removed.No damage was observed on the clip.The device was disassembled, and the trigger ears were observed to be intact, and the ratchet area had a suffice amount of grease.The knob assembly had no visible damage, and the jaw assembly was correctly assembled and displayed no signs of damage/defects.The jaws and feeder tip were undamaged.No damage was found on the box, channel or any of the tabs as well.No defects or damage were found on the device.It is important to return the device with clips remaining in order for a complete functional test to occur.No conclusive findings were able to be determined for this device.The reported complaint of "clip(s) not loading properly" could not be confirmed based upon the sample received.The device was returned with the trigger engaged and jaws closed.Functional testing was performed to reset the trigger.Ratchet sounds were observed and the jaws opened and closed as intended.The indicator clip loaded into the jaws on the first fire.No clips but the indicator clip remained in the device.The device was disassembled, and the trigger ears were observed to be intact, and the ratchet area had a suffice amount of grease.The knob assembly had no visible damage, and the jaw assembly was correctly assembled and displayed no signs of damage/defects.The jaws and feeder tip were undamaged.No damage was found on the box, channel or any of the tabs as well.No defects or damage were found on the device.It is important to receive the device with clips remaining in order to perform a complete functional test, to determine the root cause of the defect.A dhr review was performed with no evidence to suggest a manufacturing related cause.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that "during a procedure 4 clips did not load properly, the first two clips did not load properly when inserted in the patient, the doctor retracted the applier and got 4 clips to fire properly on the patient, then when we were examining the used applier after the case, we had two more clips not load properly".No patient harm or injury reported.No medical intervention required.

• 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: 23722884
• Report Number: 3003898360-2025-00888
• Device Sequence Number: 18694277
• Product Code: FZP
• UDI-Device Identifier: 14026704553126
• UDI-Public: (01)14026704553126(11)241219(17)260618(10)73M2400633(21)
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K230480
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2025

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: 06/18/2026
• Device Catalogue Number: AE05ML
• Device Lot Number: 73M2400633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2024
• 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