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

Model Number	00711095
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	10/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the reported event was returned to steris endoscopy for evaluation.The evaluation confirmed that the loop had disconnected from the device.Further review determined that the legs (bottom) of the loop appeared to be damaged.This damage may have caused an unstable bond of the drive cable loop connection which allowed the loop to disconnect.The cause of the damage to the loop could not be determined.There have been no other complaints associated with this lot.The instructions for use (732260) provides the following instructions to the user, "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." steris endoscopy offered in-service training to the user facility on the proper handling and use 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 their exacto cold snare broke off inside of the patient when retrieving a polyp.The exacto cold snare was retrieved with forceps, and the procedure was completed successfully.No report of injury or procedure delay.
Additional Manufacturer Narrative
Investigation of the reported event is currently in progress.A follow-up report will be submitted when additional information becomes available.

• 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: 20641488
• Report Number: 1528319-2024-00098
• Device Sequence Number: 17983773
• Product Code: FGX
• UDI-Device Identifier: 00724995182564
• UDI-Public: (01)00724995182564(11)240404(17)270404(10)9142058
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 11/08/2024

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: 00711095
• Device Catalogue Number: 00711095
• Device Lot Number: (10)9142058
• 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: 10/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2024
• 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