MAUDE Adverse Event Report: US ENDOSCOPY PADLOCK CLIP EFTR DEVICE

Model Number	00713229
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure the snare to their padlock clip eftr device did not deploy properly.The procedure was completed successfully using a different hot snare.No report of injury or procedure delay.
Additional Manufacturer Narrative
Our investigation into the reported event is in process.A follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The user facility returned the device subject of the reported event to steris for evaluation.Upon review of the device, it was found that the snare had gotten stuck within the housing.The reported event is likely attributed to the pusher detaching from the housing, combined with tension on the system due to the torqued endoscope configuration by user facility personnel during use on fibrotic tissue.The instructions for use includes instructions to properly deploy the clip and snare: "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." the device history record was reviewed and confirmed the lot subject of the reported event was manufactured to specifications; no abnormalities were noted.Steris performed in-service training on the proper use and operation of the padlock clip eftr device.No additional issues have been reported.

• Brand Name: PADLOCK CLIP EFTR DEVICE
• Common Device Name: PADLOCK CLIP EFTR DEVICE
• 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: 22349847
• Report Number: 1528319-2025-00072
• Device Sequence Number: 18274445
• Product Code: FDI
• UDI-Device Identifier: 00724995226732
• UDI-Public: (01)00724995226732(11)250507(17)270829(10)12375790
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

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)12375790
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2025
• 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