MAUDE Adverse Event Report: US ENDOSCOPY EXACTO; SNARE

Model Number	00711115
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation in process.A follow-up mdr will be submitted once additional information becomes available.
Event or Problem Description
The distributor reported that the snare fell off during a polyp removal and had to be retrieved with an additional snare.No report of injury.Procedure completed utilizing another device and no report of delay.
Additional Manufacturer Narrative
The device subject of the reported event has not yet been returned, the investigation is still in progress.Instructions for use packet (ifu 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." the distributor offered in-service to the user facility on the proper use and operation of the exacto cold snare; however, the user facility declined.The device history record was reviewed and confirmed the lot was manufactured according to specification; no anomalies were noted.A 3-year complaint review was conducted and confirmed this to be an isolated event.A follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The exacto cold snare subject of the reported event was not returned to the distributor for evaluation.Without the return of the product, the root cause cannot be determined.Steris will continue to monitor for similar events to ensure the product continues to perform as expected.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 ; 4403586251
• MDR Report Key: 19773537
• Report Number: 1528319-2024-00062
• Device Sequence Number: 8154491
• Product Code: FGX
• UDI-Device Identifier: 00724995182618
• UDI-Public: (01)00724995182618(11)240110(17)270110(10)8010084
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2024

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 Model Number: 00711115
• Device Catalogue Number: 00711115
• Device Lot Number: (10)8010084
• 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: 07/07/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 09/20/2024; 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2024
• 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