BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL HANDSWITCH

    MDR report key: 4802097 · Received May 28, 2015

    Report

    Report Number
    0001811755-2015-01913
    Event Type
    Malfunction
    Date Received
    May 28, 2015
    Date of Event
    May 2, 2015
    Report Date
    May 2, 2015
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    EIA
    PMA / PMN Number
    K032117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDSWITCH IS NOT A REPAIRABLE DEVICE AND WILL NOT BE RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    THE UNIVERSAL HANDSWITCH WAS RETURNED TO STRYKER INSTRUMENTS FOR SERVICE. DURING FUNCTIONAL TESTING BY A SERVICE TECHNICIAN, IT WAS FOUND THAT THE RUN/SAFE SWITCH DOES NOT HAVE DISTINCT POSITIONS, PRESENTING A POTENTIAL FOR THE DEVICE TO INADVERTENTLY BE ACTIVATED. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    THE UNIVERSAL HANDSWITCH WAS RETURNED TO STRYKER INSTRUMENTS FOR SERVICE. DURING FUNCTIONAL TESTING BY A SERVICE TECHNICIAN, IT WAS FOUND THAT THE RUN/SAFE SWITCH DOES NOT HAVE DISTINCT POSITIONS, PRESENTING A POTENTIAL FOR THE DEVICE TO INADVERTENTLY BE ACTIVATED. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345968 UNIVERSAL HANDSWITCH UNIT, OPERATIVE DENTAL EIA STRYKER INSTRUMENTS-KALAMAZOO 03245

    Patients

    Seq Age Sex Outcome Treatment
    1