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

Catalog Number	AE05ML
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the clip was loaded in a closed condition during a laparoscopic sigmoidectomy.The user tried to load the clips several times, but the same issue occurred.Therefore, a new unit was used to complete the procedure.No clip fell/remained in the patient and no injury to the patient occurred.".
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.If the sample becomes available at a later date a follow-up report will be submitted with investigation results.Teleflex will continue to monitor and trend for reports of this nature.
Additional Manufacturer Narrative
Qn#1900134241 the customer returned one unit of ae05ml auto endo5 ml lot # 73k2401020 for investigation.The serial number of the device is sn 00026733.The returned sample was visually examined without magnification.The trigger was returned partially engaged, and the jaws were closed.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 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 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.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 8 clips remaining in the channel, indicating 7 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 reported complaint of "clip(s) not opening" 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 "the clip was loaded in a closed condition during a laparoscopic sigmoidectomy.The user tried to load the clips several times, but the same issue occurred.Therefore, a new unit was used to complete the procedure.No clip fell/remained in the patient and no injury to the patient occurred.".

• 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: 23723071
• Report Number: 3003898360-2025-00892
• Device Sequence Number: 10464389
• Product Code: FZP
• UDI-Device Identifier: 14026704553126
• UDI-Public: (01)14026704553126(11)241031(17)260430(10)73K2401020(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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2025

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: 04/30/2026
• Device Catalogue Number: AE05ML
• Device Lot Number: 73K2401020
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2024
• 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