BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERPULSE HANDPIECE WITH HIGH FLOW TIP

    MDR report key: 1813015 · Received August 11, 2010

    Report

    Report Number
    2648666-2010-00345
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    July 21, 2010
    Report Date
    July 21, 2010
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    FQH
    PMA / PMN Number
    K972069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS BEING HELD AT THE ACCOUNT FOR AN INTERNAL INVESTIGATION. REQUESTS HAVE BEEN MADE TO HAVE THE DEVICE RETURNED TO THE MFR FOR A QUALITY INVESTIGATION. IF THE PRODUCT IS RECEIVED, THE INVESTIGATION WILL BE COMPLETED AND A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE BEGAN TO SMOKE DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE WITH NO ALLEGATION OF ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERPULSE HANDPIECE WITH HIGH FLOW TIP JET LAVAGE FQH STRYKER INSTRUMENTS PUERTO RICO 10154012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK