BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE DETERGENT DOCKING STATION

    MDR report key: 2531696 · Received March 28, 2012

    Report

    Report Number
    1811755-2012-01126
    Event Type
    Malfunction
    Date Received
    March 28, 2012
    Date of Event
    March 2, 2012
    Report Date
    March 2, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A MFR FIELD SERVICE TECH WAS DISPATCHED TO THE USER FACILITY TO EVALUATE THE DEVICE. VISUAL INSPECTION CONFIRMED THAT WIRES FROM THE INTERNAL OPTICAL SWITCH WAS DISASSEMBLED AND PULLED OUT OF THE DOCKER ASSEMBLY. THIS EVIDENCE INDICATES THAT SERVICE/REPAIR ACTIVITIES WERE PERFORMED ON THE DEVICE BY A NON-STRYKER SERVICE ENTITY. THESE NON-STRYKER SERVICE/REPAIR ACTIVITIES RESULTED IN THE REPORTED EXPOSED WIRES. THE INSTRUCTIONS FOR USE INCLUDE THE FOLLOWING SAFETY STATEMENT: "REPAIRS BY UNAUTHORIZED INDIVIDUALS SHOULD NOT BE ATTEMPTED AND MAY RESULT IN DAMAGE TO OR MALFUNCTION OF THE SYSTEM OR EVENT PERSONAL INJURY. NON-OPERATOR SERVICEABLE COMPONENTS SHOULD BE SERVICED BY AN AUTHORIZED STRYKER REP ONLY." THE DOCKER WAS REPAIRED AND RETURNED TO USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EVAL CONDUCTED BY A MFR SALES REP, EXPOSED WIRES WERE OBSERVED. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, SO THERE WAS NO PT INVOLVEMENT. NO USER INJURY REPORTED, AND NO OTHER ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEPTUNE DETERGENT DOCKING STATION FYD STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK