BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X7000 XENON LIGHTSOURCE

    MDR report key: 1800657 · Received August 4, 2010

    Report

    Report Number
    2936485-2010-00603
    Event Type
    Malfunction
    Date Received
    August 4, 2010
    Date of Event
    May 6, 2010
    Report Date
    July 19, 2010
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE LIGHTSOURCE INADVERTENTLY SHUT OFF. AFTER A FEW MOMENTS, THE LIGHTSOURCE WAS TURNED BACK ON AND THE CASE CONTINUED UNTIL COMPLETION. THERE WAS NO PATIENT HARM. DURING THE CASE, IT WAS NOTED THAT A NURSE HAD BUMPED THE LIGHTSOURCE WHILE USING ANOTHER DEVICE. HOWEVER, IT WAS MENTIONED THAT THE IMPACT WAS NOT HARD ENOUGH TO HAVE CAUSED THE LIGHTSOURCE TO SHUT OFF. IT WAS FURTHER REPORTED THAT THE LIGHTSOURCE WAS EVALUATED BY THE CUSTOMER AFTER THE CASE AND NO PROBLEM WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X7000 XENON LIGHTSOURCE LIGHTSOURCE FCW STRYKER ENDOSCOPY SAN JOSE 07B001724

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK