BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGILAV

    MDR report key: 1914150 · Received November 17, 2010

    Report

    Report Number
    1914150
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 17, 2010
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    FQH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    THE STRYKER SURGILAV IRRIGATOR WAS BEING USED WHEN THE NOZZLE BROKE INTO 2 PIECES, BOTH PIECES WERE RECOVERED AND ACCOUNTED FOR. NO PIECES WERE RETAINED.REFERENCE NUMBER FROM THE PACKAGE IS REF 207-559. I DO NOT RECALL WHAT CAUSED THE NOZZLE WHICH IS AN ATTACHMENT TO THE MAIN HANDPIECE FROM BREAKING. FORCE IS PROBABLY A GOOD ASSUMPTION. I CAN'T REMEMBER IF I OPENED A NEW NOZZLE OR IF WE JUST DIDN'T BOTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGILAV STRYKER SYMPULSE FQH STRYKER INSTRUMENTS 207-559 *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR