BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMB UNIVERSAL DRIVER

    MDR report key: 5183293 · Received October 28, 2015

    Report

    Report Number
    0001811755-2015-03936
    Event Type
    Malfunction
    Date Received
    October 28, 2015
    Date of Event
    October 1, 2015
    Report Date
    October 1, 2015
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K112593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING EQUIPMENT TESTING CONDUCTED BY A MANUFACTURER FIELD SERVICE TECHNICIAN THAT THE DEVICE DISPLAYED A BIAS CURRENT ERROR THAT COULD RESULT IN UNINTENDED ACTIVATION OR RUN-ON. NO PATIENT INVOLVEMENT, NO CLINICALLY SIGNIFICANT DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714646 REMB UNIVERSAL DRIVER DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1