BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER

    MDR report key: 1343948 · Received March 12, 2009

    Report

    Report Number
    MW5010306
    Event Type
    Malfunction
    Date Received
    March 12, 2009
    Date of Event
    March 3, 2009
    Report Date
    March 12, 2009
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    KQT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BATTERY LEAK OBSERVED DURING SURGERY. A PULSE LAVAGE IRRIGATOR WAS IN USE WHEN THE O.R. NURSE NOTICED A WEAK STREAM OF IRRIGANT. THE O.R. NURSE INSPECTED THE DEVICE MORE CLOSELY AND SAW THE CORROSIVE SUBSTANCE AT JUNCTURE OF THE BATTERY PACK. SOME RESIDUE ALSO SEEN ON TUBING. THE PULSE LAVAGE IRRIGATOR WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER PULSE LAVAGE IRRIGATOR KQT STRYKER INSTRUMENTS 210-114-100

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR