BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGILAV PLUS HANDPIECE SET WITH MULTI-ORIFICE TIP

    MDR report key: 1892527 · Received November 2, 2010

    Report

    Report Number
    2648666-2010-00443
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 18, 2010
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    FQH
    PMA / PMN Number
    K972069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. THE INSTRUCTIONS FOR USE THAT ARE SUPPLIED WITH EACH DEVICE HAVE A WARNING THAT STATES: "DO NOT CUT THE POWER PACK FROM THE UNIT FOR DISPOSAL. CUTTING THROUGH THE POWER CABLE COULD RESULT IN SHOCK, EXCESSIVE HEAT AND/OR SPARKS, WHICH MAY CAUSE PERSONAL INJURY AND/OR FIRE." THE ACCOUNT HAS BEEN RE-TRAINED ON THE IFU AND THE SAFE REMOVAL OF THE BATTERIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE PROCEDURE WAS COMPLETE, THE CORD BETWEEN THE BATTERY PACK AND THE HANDPIECE WAS CUT. THE BATTERY PACK FELL ON THE FLOOR AND EMITTED SPARKS AS IT BOUNCED. THERE WERE NO ALLEGATIONS OF ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGILAV PLUS HANDPIECE SET WITH MULTI-ORIFICE TIP JET LAVAGE FQH STRYKER INSTRUMENTS PUERTO RICO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK