BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERPULSE HANDPIECE SET W/

    MDR report key: 3051574 · Received April 10, 2013

    Report

    Report Number
    0001811755-2013-00750
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 14, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FQH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 ALL THE ELECTRICAL COMPONENTS. THE MOTOR HOUSING AND SHAFT WERE RUSTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE INTERPULSE HANDPIECES WERE OBSERVED TO LEAK A SUBSTANCE DURING PREPARATION FOR A PROCEDURE. THERE WERE NO ALLEGATIONS OF THE SUBSTANCE COMING INTO CONTACT WITH THE SURGICAL SITE. THERE WERE NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE INTERPULSE HANDPIECES WERE OBSERVED TO LEAK A SUBSTANCE DURING PREPARATION FOR A PROCEDURE. THERE WERE NO ALLEGATIONS OF THE SUBSTANCE COMING INTO CONTACT WITH THE SURGICAL SITE. THERE WERE NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149205 INTERPULSE HANDPIECE SET W/ LAVAGE, JET FQH STRYKER INSTRUMENTS-KALAMAZOO 13023012

    Patients

    Seq Age Sex Outcome Treatment
    1 INTERPULSE HANDPIECE: UNKNOWN SERIAL NUMBER| INTERPULSE HANDPIECE: UNKNOWN SERIAL NUMBER