BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPS HANDPIECE CORD

    MDR report key: 4102734 · Received September 19, 2014

    Report

    Report Number
    0001811755-2014-03305
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    EIA
    PMA / PMN Number
    K032117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF BIAS CURRENT ERROR WAS CONFIRMED BY THE ENGINEERING TECHNICIAN THROUGH FUNCTIONAL EVALUATION. DURING THE DEVICE INSPECTION, THE TECHNICIAN DETERMINED THE CABLE¿S INTERNAL WIRING WAS DAMAGED, WHICH MAY CAUSE OR CONTRIBUTE TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION; ADDITIONAL INFORMATION MAY BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING BY A MANUFACTURER FIELD SERVICE TECHNICIAN AT THE USER FACILITY, THE TPS HANDPIECE CORD CAUSED A BIAS CURRENT MESSAGE TO BE DISPLAYED, SIGNALING A CONDITION OCCURRED IN WHICH THE HANDPIECE HAS THE POTENTIAL TO RUN WITHOUT USER ACTIVATION. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING BY A MANUFACTURER FIELD SERVICE TECHNICIAN AT THE USER FACILITY, THE TPS HANDPIECE CORD CAUSED A BIAS CURRENT MESSAGE TO BE DISPLAYED, SIGNALING A CONDITION OCCURRED IN WHICH THE HANDPIECE HAS THE POTENTIAL TO RUN WITHOUT USER ACTIVATION. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583877 TPS HANDPIECE CORD UNIT, OPERATIVE DENTAL EIA STRYKER INSTRUMENTS-KALAMAZOO 09030

    Patients

    Seq Age Sex Outcome Treatment
    1