BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRRIGATION ONLY TIP

    MDR report key: 1892526 · Received November 2, 2010

    Report

    Report Number
    2648666-2010-00446
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 11, 2010
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    FQH
    PMA / PMN Number
    K972069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AT THE ACCOUNT. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE DEVICE DISASSEMBLED FROM THE HANDPIECE DURING A PROCEDURE. THERE WAS NO REPORT OF ANYTHING FALLING INTO THE SURGICAL SITE. THE ACCOUNT HAD A BACK UP ON HAND TO COMPLETE THE PROCEDURE WITH NO DELAY. THERE ARE NO ALLEGATIONS OF ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IRRIGATION ONLY TIP JET LAVAGE FQH STRYKER INSTRUMENTS PUERTO RICO 10056012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK