BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARI-TIP ELECTRODE

    MDR report key: 7481309 · Received May 2, 2018

    Report

    Report Number
    2428235-2018-00002
    Event Type
    Injury
    Date Received
    May 2, 2018
    Date of Event
    January 18, 2018
    Report Date
    May 2, 2018
    Manufacturer
    CYNOSURE, INC. DBA ELLMAN
    Product Code
    GEI
    PMA / PMN Number
    K071343
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER WAS UNABLE TO PROVIDE PATIENT DETAILS OR A DEVICE EVALUATION REGARDING THE EVENT. HOWEVER, WITH THE LIMITED INFORMATION AVAILABLE IT WAS CONFIRMED THAT USER ERROR WAS THE ROOT CAUSE BECAUSE THE OPERATOR DID NOT FOLLOW INSTRUCTIONS PER THE IFU. THE ELECTRODE WAS ADJUSTABLE, BUT THE OPERATOR DID NOT FOLLOW THIS AND ENDED UP BREAKING IT. THE PATIENT DETAILS WERE NOT PROVIDED, BUT THE EVENT TOOK PLACE DURING A TONSILLECTOMY PROCEDURE WHERE THE OPERATOR BROKE THE RF ELECTRODE. THIS RESULTED IN THE METAL PART OF THE RF ELECTRODE REMAINING ATTACHED TO THE PATIENT'S AMYGDALA. THE OPERATOR RESOLVED THE ISSUE BY REMOVING THE ELECTRODE FROM THE PATIENT AND CONTINUED FORWARD WITH THE PROCEDURE USING A REPLACEMENT RF ELECTRODE. THIS IS REPORTABLE BECAUSE THE INCIDENT IS A POTENTIAL SERIOUS INJURY EVENT.

    Description of Event or Problem · 1

    USER BROKE AN RF ELECTRODE WHILE TREATING A PATIENT DURING A TONSILLECTOMY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321645 VARI-TIP ELECTRODE VARI-TIP ELECTRODE GEI CYNOSURE, INC. DBA ELLMAN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other