BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE MICRO DRILL

    MDR report key: 4243664 · Received November 11, 2014

    Report

    Report Number
    0001811755-2014-04039
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 15, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K112593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS NOT CONFIRMED AS THE PRODUCT WAS NOT RECEIVED FOR EVALUATION. DEVICE NOT RETURNED TO MANUFACTURER FOR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE MAINTENANCE CONDUCTED BY A MANUFACTURER FIELD SERVICE TECHNICIAN AT THE USER FACILITY THE CORE MICRO DRILL WAS ABLE TO RUN IN SAFE MODE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE MAINTENANCE CONDUCTED BY A MANUFACTURER FIELD SERVICE TECHNICIAN AT THE USER FACILITY THE CORE MICRO DRILL WAS ABLE TO RUN IN SAFE MODE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727937 CORE MICRO DRILL DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1