MAUDE Adverse Event Report: US ENDOSCOPY EXACTO; SNARE

Model Number	00711094
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Cut (2587)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure their exacto cold snare would not cut through a polyp and became stuck.User facility personnel cut the handle of the snare to remove the scope and the patient was transferred to another facility to have the snare wire removed.The patient was discharged the next day.
Additional Manufacturer Narrative
Steris has requested the device subject of the event to be returned for evaluation.The investigation into the reported event is in progress.A follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
A returned sample of unused devices from the same lot associated with the event was evaluated.The reported issue of the device failing to release could not be duplicated.Based on the evaluation findings, the cause of the reported event could not be determined.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.The instructions for use states the following, "prior to clinical use, inspect and familiarize yourself with the device.If there is evidence of damage, do not use this product and contact your local product specialist.Attempting to advance the handle to the open position with too much speed or force, attempting to pass or open the device in an extremely articulated endoscope, attempting to actuate the device in an extremely coiled position and/or, attempting to actuate the device when the handle is at an acute angle in relation to the sheath." steris will continue to monitor for similar events to ensure the product continues to perform as expected.No additional issues have been reported.

• Brand Name: EXACTO
• Common Device Name: SNARE
• 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: 24328344
• Report Number: 1528319-2026-00010
• Device Sequence Number: 21188097
• Product Code: FGX
• UDI-Device Identifier: 00724995182557
• UDI-Public: (01)00724995182557(11)250417(17)280417(10)12242963
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

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: 00711094
• Device Catalogue Number: 00711094
• Device Lot Number: (10)12242963
• 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: 01/29/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2025
• 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