MAUDE Adverse Event Report: US ENDOSCOPY EXACTO; SNARE

Model Number	00711115
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	09/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation into the reported event is in progress.A follow-up report will be submitted when additional information becomes available.Udi related data clarification: the lot/serial number is unknown; therefore, the applicable production identifiers were not included in the mdr.
Event or Problem Description
The user facility reported that during a patient procedure, the patient experienced a perforation with the use of an exacto cold snare.The user facility did not disclose whether additional medical treatment was required.
Additional Manufacturer Narrative
A steris account manager has made multiple attempts to obtain additional information regarding the reported event; however, the user facility did not provide any additional information.The device subject of the event was discarded and not returned for evaluation.Without return of the device, the cause of the reported event could not be determined.The initial report included two lot numbers (12243026 and 12243023).It is unknown which lot was used at the time of the reported event.The dhrs for both lots were reviewed and confirmed the lots were manufactured to specifications; no abnormalities were noted.The exacto cold snare instructions for use states, "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.The following conditions may cause the device to not function properly: 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." no additional issues have been reported.

• Brand Name: EXACTO
• Common Device Name: SNARE
• 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: 23438914
• Report Number: 1528319-2025-00102
• Device Sequence Number: 21000740
• Product Code: FGX
• UDI-Device Identifier: 00724995182618
• UDI-Public: (01)00724995182618
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 10/31/2025

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: 00711115
• Device Catalogue Number: 00711115
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 12/08/2025
• 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