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

Model Number	00711115
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the reported event was not returned for investigation.Without the returned device, a root cause cannot be determined.The exacto cold snare instructions for use packet (ifu 732260) 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." the device history record was reviewed and confirmed the lot was manufactured to specifications; no abnormalities were noted.A 3-year complaint review indicates this to be an isolated event for this lot.In-service was offered on the proper use and operation of the exacto cold snare, however the user facility declined.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a colonoscopy, their exacto cold snare was placed around a large polyp and broke.The length of wire remaining was removed with biopsy forceps while the polyp was retrieved with another device.The procedure was completed successfully.No report of injury.

• Brand Name: EXACTO
• Common Device Name: EXACTO COLD SNARE
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor OH
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4404130648
• MDR Report Key: 20736841
• Report Number: 1528319-2024-00103
• Device Sequence Number: 8377578
• Product Code: FGX
• UDI-Device Identifier: 00724995182618
• UDI-Public: (01)00724995182618(11)240717(17)270717(10)10768051
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 11/20/2024

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
• Device Lot Number: (10)10768051
• 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: 10/21/2024
• Initial Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2024
• 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