BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMB UNIVERSAL DRIVER

    MDR report key: 3895115 · Received June 25, 2014

    Report

    Report Number
    0001811755-2014-02273
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K112593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT THAT THE DEVICE SPARKED WAS UNABLE TO BE DUPLICATED.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REMB UNIVERSAL DRIVER SPARKED DURING A PROCEDURE AT THE USER FACILITY; THE USER COULD NOT IDENTIFY WHERE THE SPARK CAME FROM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH BACK-UP EQUIPMENT; NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REMB UNIVERSAL DRIVER SPARKED DURING A PROCEDURE AT THE USER FACILITY; THE USER COULD NOT IDENTIFY WHERE THE SPARK CAME FROM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH BACK-UP EQUIPMENT; NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372105 REMB UNIVERSAL DRIVER DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1