BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGILAV PLUS HANDPIECE SET WITH MULTI-ORIFICE TIP

    MDR report key: 1945906 · Received December 28, 2010

    Report

    Report Number
    2648666-2010-00506
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    December 15, 2010
    Report Date
    December 15, 2010
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    FQH
    PMA / PMN Number
    K972069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AT THE ACCOUNT. THE DEVICE HISTORY RECORD AND THE NON-CONFORMANCE REPORT DATABASE WERE REVIEWED FOR INCIDENTS RELATED TO THE REPORTED PART NUMBER AND LOT NUMBERS AND FOR INCIDENTS RELATED TO THE ABOVE CONDITION WITHIN A 2 WEEKS PERIOD (+/-) FROM THE LOT MANUFACTURING DATE. NO RELATED NON-CONFORMANCES OR DEVIATION REPORTS WERE FOUND THAT COULD CONTRIBUTE TO THE FAILURE ADDRESSED IN THIS COMPLAINT. NO PROCESS OR DESIGN CHANGES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HEATED UP DURING A PROCEDURE. THE ACCOUNT HAD A BACK UP ON HAND TO COMPLETE THE CASE WITH NO DELAY. 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 10270012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK