BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERPULSE HANDPIECE SET WITH 10 FOOT SUCTION TUBING

    MDR report key: 2932786 · Received January 29, 2013

    Report

    Report Number
    0001811755-2013-00066
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 2, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FQH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE FILED AFTER THE QUALITY INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    UPON DISASSEMBLY FOR VISUAL INSPECTION CORROSION WAS FOUND ON THE BATTERIES AND THE BATTERY HOLDER CONTACTS. ONE CONTACT WAS ALSO BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERIES WERE LEAKING FROM THE INTERPULSE HANDPIECE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE, BUT WERE NOT SUCCESSFUL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERIES WERE LEAKING FROM THE INTERPULSE HANDPIECE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE, BUT WERE NOT SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39118 INTERPULSE HANDPIECE SET WITH 10 FOOT SUCTION TUBING LAVAGE, JET FQH STRYKER INSTRUMENTS-KALAMAZOO 12105012

    Patients

    Seq Age Sex Outcome Treatment
    1