BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRRIGATION ONLY EXTENDED TIP

    MDR report key: 1791543 · Received July 23, 2010

    Report

    Report Number
    2648666-2010-00318
    Event Type
    Malfunction
    Date Received
    July 23, 2010
    Date of Event
    July 6, 2010
    Report Date
    July 6, 2010
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    FQH
    PMA / PMN Number
    K972069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AT THE ACCOUNT. A PICTURE OF THE DISASSEMBLED DEVICE WAS FORWARDED, SO THE ALLEGED CONDITION WAS CONFIRMED. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO RELATED NON-CONFORMANCES OR DEVIATIONS WERE FOUND THAT COULD CONTRIBUTE TO THE FAILURE ADDRESSED IN THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IRRIGATION TIP DISASSEMBLED INTO TWO PARTS. THIS DID NOT OCCUR DURING A PROCEDURE. NOTHING FELL INTO THE SURGICAL SITE AND THE ACCOUNT HAD A BACK UP TO COMPLETE THE PROCEDURE WITH NO DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IRRIGATION ONLY EXTENDED TIP JET LAVAGE FQH STRYKER INSTRUMENTS PUERTO RICO 10102012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK