BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS EMPOWER H65

    MDR report key: 14446693 · Received May 19, 2022

    Report

    Report Number
    3004378299-2022-00100
    Event Type
    Malfunction
    Date Received
    May 19, 2022
    Date of Event
    April 14, 2022
    Report Date
    May 19, 2022
    Manufacturer
    QUANTA SYSTEM S.P.A.
    Product Code
    GEX
    UDI-DI
    08059173390045
    PMA / PMN Number
    K180423
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOOTSWITCH FAILURE: IT IS UNKNOW IF THE FOOTSWITCH WAS ASSOCIATED TO OLYMPUS EMPOWER H65 (K180423) OR OLYMPUS EMPOWER H100 (K180922). WE ARE UNAWARE ABOUT OPERATOR/PATIENT INJURY.

    Description of Event or Problem · 0

    DAMAGED FOOTSWITCH CABLE, IT WAS POSSIBLE TO CONCLUDE TREATMENTE KEEPING IT STRAIGHT IN A CERTAIN POSITION. NO ADVERSE EFFECTS TO PATIENT/OPERATOR WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400747 OLYMPUS EMPOWER H65 SURGICAL LASER GEX QUANTA SYSTEM S.P.A. EMP-H65 08059173390045

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown