MAUDE Adverse Event Report: US ENDOSCOPY PADLOCK CLIP EFTR DEVICE

Model Number	00713229
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported following use of their padlock clip eftr kit a "superficial thermal injury to the mucosa" was observed on the lumen wall opposite the resection site.No medical treatment administered.No report of delay.
Additional Manufacturer Narrative
The padlock clip eftr kit subject of the reported event was discarded by user facility personnel prior to being returned for evaluation.Without the return of the device, a cause cannot be determined.A steris account manager conducted in-service training with user facility personnel on the proper use and operation to the padlock clip eftr kit.The device history record for the subject lot was reviewed and confirmed the device was manufactured to specifications; no abnormalities were noted.A complaint review was conducted for this lot of products and confirmed this to be an isolated event.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 OH 44060
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 24270738
• Report Number: 1528319-2026-00008
• Device Sequence Number: 10726260
• Product Code: FDI
• UDI-Device Identifier: 00724995226732
• UDI-Public: (01)00724995226732(11)251203(17)280807(10)13208357
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 02/05/2026

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
• Device Lot Number: (10)13208357
• 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: 01/08/2026
• Initial Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/03/2025
• 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