BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOANER REMB ELC WIREDRIVER

    MDR report key: 4192824 · Received October 22, 2014

    Report

    Report Number
    0001811755-2014-03718
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K112593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS NOT DUPLICATED; HOWEVER, UPON VISUAL INSPECTION, THE DIAGNOSTIC ENGINEER FOUND DELAMINATING FLEX. THE DEVICE WAS REPAIRED AND PLACED BACK INTO STRYKER STOCK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP FOR A PROCEDURE AT THE USER FACILITY, THE REMB ELECTRIC WIREDRIVER WAS RUNNING WITHOUT USER ACTIVATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO DELAY, NO ADVERSE CONSEQUENCES, AND MEDICAL INTERVENTION WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP FOR A PROCEDURE AT THE USER FACILITY, THE REMB ELECTRIC WIREDRIVER WAS RUNNING WITHOUT USER ACTIVATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO DELAY, NO ADVERSE CONSEQUENCES, AND MEDICAL INTERVENTION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673500 LOANER REMB ELC WIREDRIVER DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1