MAUDE Adverse Event Report: US ENDOSCOPY PADLOCK CLIP; PADLOCK CLIP STANDARD

Model Number	C910001
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Ulcer (2274)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the reported event is being returned to steris for evaluation.Investigation of the reported event is in progress.A follow-up report will be submitted once additional information becomes available.
Event or Problem Description
The user facility reported via vigilance report that during a patient procedure their padlock clip standard failed to deploy after the clip was used to treat a bleeding ulcer.The clip was removed and the procedure was completed successfully.
Additional Manufacturer Narrative
The device subject of the reported event was not returned to steris for evaluation.Without the returned device, a root cause of the reported event could not be determined.The padlock clip ifu states, "check to ensure that the scope is inserted completely into the scope mounting feature of the delivery housing and that the housing isn't expanded.Too tight of a fit can expand the scope mounting feature making the pushing mechanism sluggish and allow the padlock clip® to get hung up on deployment, especially in retroflexion.If any clip points extend beyond distal rim/edge, carefully replace safety cap, do not use this product, contact your local product specialist or customer service representative, and use a different device for procedure." a steris account manager offered in-service training on the proper use and operation of the padlock lip, however the user facility declined.A complaint review confirmed this to be an isolated event for the subject lot.No additional issues have been reported.

• Brand Name: PADLOCK CLIP
• Common Device Name: PADLOCK CLIP STANDARD
• 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: 23585889
• Report Number: 1528319-2025-00106
• Device Sequence Number: 13156054
• Product Code: PKL
• UDI-Device Identifier: 00724995184247
• UDI-Public: (01)00724995184247(11)231228(17)261228(10)8010002
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 11/18/2025

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: C910001
• Device Catalogue Number: C910001
• Device Lot Number: (10)8010002
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/28/2023
• 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