BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGILAV PLUS HANDPIECE SET WITH MULTI-ORIFICE TIP

    MDR report key: 1945873 · Received December 17, 2010

    Report

    Report Number
    2648666-2010-00496
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 15, 2010
    Report Date
    December 8, 2010
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    FQH
    PMA / PMN Number
    K972069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS BEING HELD AT THE ACCOUNT. NO LOT NUMBER HAS BEEN PROVIDED FOR A DEVICE HISTORY RECORD REVIEW. IF ADDITIONAL INFO IS RECEIVED, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE DEVICE BROKE WHILE IN USE. ALL PIECES WERE ACCOUNTED FOR. THERE IS NO ALLEGATION OF ADVERSE CONSEQUENCES ALLEGED IN 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK