BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO RECIPROCATING SAW

    MDR report key: 2941845 · Received December 21, 2012

    Report

    Report Number
    1811755-2012-04313
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORROSION WAS FOUND IN THE MOTOR AND DAMAGE WAS FOUND IN THE CONTACT PINS, WHICH ARE PROBABLE CAUSES OF THE DEVICE RUNNING WITHOUT USER ACTIVATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE SAW WAS RUNNING SLOWLY WITHOUT USER ACTIVATION, AFTER HAVING BEEN IN USE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO RECIPROCATING SAW ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK