BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X6000 XENON LIGHT SOURCE

    MDR report key: 1017355 · Received March 18, 2008

    Report

    Report Number
    2936485-2008-00014
    Event Type
    Malfunction
    Date Received
    March 18, 2008
    Date of Event
    January 22, 2008
    Report Date
    February 18, 2008
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    GCT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED, UPON COMPLETION OF THE COMPLAINT INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STAFF IN THE OPERATING ROOM REPORTED SMELLING AN ODD ODOR AND WERE UNABLE TO FIND THE SOURCE INITIALLY. OXYGEN WAS SHUT OFF AND PT DRAPES REMOVED TO ASSESS PT SAFELY. SMOKE WAS NOTED TO BE POURING FROM THE LIGHT SOURCE ON THE VIDEO TOWER. THE PT REMAINED SAFE AND VENTILATED, AND THE SURGICAL PROCEDURE WAS COMPLETED. TWO STAFF MEMBERS REQUIRED EVALUATION AND TREATMENT IN THE EMERGENCY ROOM - ONE HAD TREATMENT FOR AN ASTHMA ATTACK RELATIVE TO SMOKE INHALATION AND THE OTHER WAS TREATED FOR A HEADACHE RELATIVE TO SMOKE INHALATION. BOTH STAFF MEMBERS RETURNED TO WORK AFTER BEING TREATED. THE HOSPITAL'S BIOMED DEPT. HAD REPLACED A STAND-BY SWITCH ONE WEEK PRIOR TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X6000 XENON LIGHT SOURCE LIGHT SOURCE GCT STRYKER ENDOSCOPY SAN JOSE 02K023804

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK