BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER INTERPULSE

    MDR report key: 1929494 · Received November 17, 2010

    Report

    Report Number
    1929494
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 17, 2010
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    FQH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE STRYKER INTERPULSE WAS LEAKING BROWN FLUID. THE FIRST STRYKER INTERPULSE WAS REMOVED FROM SURGICAL FIELD. A SECOND STRYKER INTERPULSE WAS OBTAINED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THE PATIENT WAS TAKEN TO RECOVERY ROOM IN STABLE CONDITION. THE SURGEON EXAMINED THE FIRST STRYKER INTERPULSE AND FOUND THE INSIDES COVERED WITH BROWN FLUID. CHOICE SPINE REPRESENTATIVE TOOK PHOTOS. CHOICE SPINE REPRESENTATIVE BAGGED THE STRYKER INTERPULSE ALONG WITH PACKAGE INFORMATION. CHOICE SPINE REPRESENTATIVE WILL MAKE STRYKER INSTRUMENTS AWARE OF THE PROBLEM WITH THE STRYKER INTERPULSE.====================== HEALTH PROFESSIONAL'S IMPRESSION======================UNKNOWN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER INTERPULSE ORTHOPAEDIC SURGICAL INSTRUMENT FQH STRYKER INSTRUMENTS 210-110 10243012

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR