MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. ISNARE SYSTEM - OVAL SNARE

Model Number	00711086
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of this complaint is not available for return to steris endoscopy for evaluation.The device history record was reviewed and confirmed the device lot was manufactured to specification.There have been no other complaints associated with this lot.Statements in the instructions for use include: "short strokes, 1"-1.5" (2.5cm - 3.8cm) in length, are recommended throughout device passage to avoid catheter kinking.Before reinserting the device into the endoscope, check to confirm that the needle and snare function and that they are in a retracted position." the distributor has offered in-service training on the use of the isnare system - oval snare to the user facility; however, the facility has not yet responded.No further issues have been reported.
Event or Problem Description
The user facility reported that the snare loop of an isnare system - oval snare detached from the device during procedural use.The procedure was completed with another snare and the detached component was retrieved.There was no reported harm to the patient or user of the device.

• Brand Name: ISNARE SYSTEM - OVAL SNARE
• Common Device Name: ISNARE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 11426767
• Report Number: 1528319-2021-00007
• Device Sequence Number: 16858204
• Product Code: FDI
• UDI-Device Identifier: 00724995180805
• UDI-Public: (01)00724995180805
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K040961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/05/2021

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: 11/09/2023
• Device Model Number: 00711086
• Device Catalogue Number: 00711086
• Device Lot Number: 2010896
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 03/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1