BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPS HANDPIECE CORD

    MDR report key: 1584173 · Received January 13, 2010

    Report

    Report Number
    1811755-2010-00040
    Event Type
    Injury
    Date Received
    January 13, 2010
    Date of Event
    December 15, 2009
    Report Date
    December 16, 2009
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    GEY
    PMA / PMN Number
    K032117
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CORD WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CORD TO THE HANDPIECE WAS UNINTENTIONALLY CUT, AND A NURSE WAS SHOCKED WHEN SHE TOUCHED IT, WHILE PREPPING FOR A SURGICAL PROCEDURE. THERE WAS NO PATIENT INJURY, AND THE PLANNED PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER A SWITCH TO ANOTHER DEVICE. THE NURSE THAT WAS SHOCKED RECEIVED SOME TREATMENT, BUT THERE WAS NO ADDITIONAL/ONGOING TREATMENT REQUIRED OR ANY PERMANENT DAMAGE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TPS HANDPIECE CORD SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTAC GEY STRYKER INSTRUMENTS KALAMAZOO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1