BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE ELECTROSURGICAL SNARE

    MDR report key: 4212813 · Received October 24, 2014

    Report

    Report Number
    2951238-2014-00454
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 8, 2014
    Manufacturer
    OLYMPUS MEDICAL SYS CORP
    Product Code
    FDI
    PMA / PMN Number
    K955650
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION, AS IT HAS BEEN DISCARDED FOLLOWING THE PROCEDURE BY THE USER FACILITY. IF ADDITIONAL INFO BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A POLYPECTOMY PROCEDURE, THE SNARE WOULD NOT DETACH FROM THE POLYP. THE PT WAS TRANSFERRED TO THE HOSP FOR A SURGICAL PROCEDURE TO REMOVE THE POLYP. IT WAS STATED THAT THE SNARE WAS REMOVED USING A WIRE CUTTER. THERE WERE NO FURTHER COMPLICATIONS REPORTED. THE DEVICE WAS DISCARDED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678597 DISPOSABLE ELECTROSURGICAL SNARE ELECTROSURGICAL FDI OLYMPUS MEDICAL SYS CORP SD-240U-25 39V

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention