BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    300 WATT XENON LIGHT SOURCE

    MDR report key: 5774219 · Received July 6, 2016

    Report

    Report Number
    1221826-2016-00100
    Event Type
    Malfunction
    Date Received
    July 6, 2016
    Date of Event
    May 4, 2016
    Report Date
    June 6, 2016
    Manufacturer
    KARL STORZ ENDOVISION
    Product Code
    GCT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIGHT SOURCE WILL NOT BE RETURNED BY THE HOSPITAL. THE BIOMED AT THE HOSPITAL PROVIDED A REPORT ALONG WITH PICTURES AND SENT TO US. BASED ON THE REPORT AND PICTURES, THE MANUFACTURER PROVIDES A POSSIBLE EVALUATION: WE REVIEWED THE EVALUATION REPORT FROM THE BIOMEDICAL ENGINEER FROM CREDIT VALLEY. KSE ASSESSMENT BELOW: PROBLEM: A SHORT OCCURRED BETWEEN THE NEGATIVE POWER LINE FOR THE LAMP ASSEMBLY AND THE HIGH VOLTAGE POWER BOARD. KSE ASSESSMENT: IT APPEARS FROM THE PICTURE THAT THE INSULATION ON THE NEGATIVE HIGH VOLTAGE LEAD CAME IN CONTACT WITH THE LAMP POWER SUPPLY PLATE. THE LIKELY CAUSE COULD BE IMPROPER CABLE ROUTING, OR DAMAGED/MISSING CABLE TIE. THIS CABLE TIE IS USED TO MAINTAIN THE POSITION OF THE NEGATIVE HIGH VOLTAGE LEAD. UNIT IS TEN (10) YEARS OLD. SHIPPED TO CUSTOMER IN 11/2006. NO HISTORY OF SERVICE REPAIR. WE THINK IT POSSIBLE THAT THIS UNIT HAS BEEN REPAIRED AND MAINTAINED BY 3RD PARTY. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    ALLEGEDLY, DURING A CYSTOLITHOLAPAXY/TURP, THE LIGHT SOURCE STARTED SMOKING. THE SURGEON HAD TO ABORT THE CASE AND CLEAR THE ROOM. THERE WAS NO REPORT OF INJURY TO THE PATIENT. THEY USED A POWDER TYPE FIRE EXTINGUISHER TO SPRAY UNIT DOWN. UNIT WAS REMOVED FROM SERVICE AND BROUGHT DOWN TO HOSPITAL'S BIOMEDICAL DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427765 300 WATT XENON LIGHT SOURCE LIGHT SOURCE GCT KARL STORZ ENDOVISION 201331-20-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention