MAUDE Adverse Event Report: US ENDOSCOPY PADLOCK CLIP EFTR

Model Number	00713229
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The padlock clip eftr kit was not returned for evaluation.Without the return and evaluation of the device the cause of the event could not be determined.The instructions for use states, "grasping or placing a clip to severely fibrotic lesions for excision may be more difficult.Deploy clip and snare by squeezing thumb ring and spool in one steady controlled motion until spool approaches thumb ring, and the snare is tightly closed around the tissue.Step 1: deploy clip and snare in one steady controlled motion." one steady controlled motion is necessary to avoid losing placement of snare over the lesion.Release tension on the catheter of the grasping device at the biopsy port by the physician prior to deploying the clip and snare.".No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure the padlock clip eftr kit would not deploy.The doctor elected to leave the tissue without doing a resection.No report of injury.

• Brand Name: PADLOCK CLIP EFTR
• Common Device Name: PADLOCK CLIP EFTR
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor 44060
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor 44060 ; 4403586251
• MDR Report Key: 23095276
• Report Number: 1528319-2025-00095
• Device Sequence Number: 21015425
• Product Code: FDI
• UDI-Device Identifier: 00724995226732
• UDI-Public: (01)00724995226732(11)250723(17)270829(10)12659091
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K250842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 00713229
• Device Catalogue Number: 00713229
• Device Lot Number: (10)12659091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2025
• 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
• Patient Sex: Unknown