BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPS HANDPIECE CORD

    MDR report key: 3092225 · Received May 3, 2013

    Report

    Report Number
    0001811755-2013-01023
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 12, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TPS HANDPIECE CORD CAUSED A HANDPIECE TO RUN WITHOUT USER ACTIVATION DURING A ROUTINE EQUIPMENT EVALUATION AT THE USER FACILITY, BY A MANUFACTURER'S SERVICE TECHNICIAN. THERE WAS NO PATIENT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194447 TPS HANDPIECE CORD EAR, NOSE, AND THROAT ELECTRIC OR PNEUMATIC SURGICAL DRILL. ERL STRYKER INSTRUMENTS-KALAMAZOO 10228

    Patients

    Seq Age Sex Outcome Treatment
    1