MAUDE Adverse Event Report: US ENDOSCOPY EXACTO; SNARE

Model Number	00711115
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our investigation into the reported event is in process.Steris requested the device to be returned for investigation.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported via vigilance report to ansm that during a patient procedure their exacto cold snare unfolds a quarter of the way inside and outside the endoscope.The user facility used another exacto cold snare, and the procedure was completed successfully.No injury was reported.
Additional Manufacturer Narrative
The exacto cold snare subject of the reported event was not returned for an investigation.Without the return of the complaint device, the exact cause of the reported issue cannot be determined.The customer's steris distributor was contacted multiple times to retrieve the exacto cold snare but was unable to be returned for an evaluation.Without the return of the exacto cold snare subject of the reported event, the root cause cannot be determined.The exacto cold snare ifu 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 OH 44060
• 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: 19951448
• Report Number: 1528319-2024-00065
• Device Sequence Number: 21033035
• Product Code: FGX
• UDI-Device Identifier: 00724995182618
• UDI-Public: (01)00724995182618(11)230920(17)260920(10)7032042
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 08/09/2024

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 Expiration Date: 09/20/2026
• Device Model Number: 00711115
• Device Catalogue Number: 00711115
• Device Lot Number: (10)7032042
• 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: 07/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2023
• 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