MAUDE Adverse Event Report: US ENDOSCOPY EXACTO; EXACTO COLD SNARE

Model Number	00711115
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Steris requested the exacto cold snare subject of the reported event be returned for evaluation.The device history record was reviewed for the subject lot and no abnormalities were noted.A complaint review was performed and confirmed the event to be isolated for the subject lot.It should be noted that steris is submitting an mdr solely due to the receipt of the user facility medwatch report which is in accordance with our policies and procedures.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported via medwatch#: (b)(4) that their "exacto cold snare would not completely come out of the device." no report of injury or procedure delay.
Additional Manufacturer Narrative
The exacto cold snare subject of the reported event was returned for evaluation.The exacto cold snare was observed to have multiple kinks/bends.Further review of the device found that the loop deployed as expected with no issues; the reported event could not be duplicated.The kinks/bends could be an indication that user facility personnel had the device in an extremely coiled position, which could cause the device to not function properly.The 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." user facility personnel were counseled on the proper use and operation of the exacto cold snare.No additional issues have been reported.

• Brand Name: EXACTO
• Common Device Name: EXACTO COLD 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 ; 4404130648
• MDR Report Key: 21861941
• Report Number: 1528319-2025-00034
• Device Sequence Number: 20812380
• Product Code: FGX
• UDI-Device Identifier: 00724995182618
• UDI-Public: (01)00724995182618(11)241111(17)271111(10)11296004
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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): 04/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 00711115
• Device Catalogue Number: 00711115
• Device Lot Number: (10)11296004
• 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: 03/18/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2024
• 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