MAUDE Adverse Event Report: US ENDOSCOPY PADLOCK CLIP EFTR

Model Number	00713229
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that following a completed procedure that utilized the padlock clip eftr kit, the patient came back with blood from the vessel at the clip location.The vessel was treated.
Additional Manufacturer Narrative
The device subject of the reported event was not returned to steris for evaluation.Without the returned device, a cause of the reported event could not be determined.The padlock clip eftr kit 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." the user facility accepted in-service training on the proper use and operation of the padlock clip eftr kit.A follow-up report will be submitted once the in-service is completed.Udi related data clarification - the lot/serial number is unknown, therefore, the applicable production identifiers were not included in the mdr.

• Brand Name: PADLOCK CLIP EFTR
• Common Device Name: CLIP
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5976 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 25394905
• Report Number: 1528319-2026-00063
• Device Sequence Number: 5191775
• Product Code: PKL
• UDI-Device Identifier: 00724995226732
• UDI-Public: (01)00724995226732
• 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): 06/04/2026

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
• 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: 05/06/2026
• Initial Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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