BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LX300, TURRET 300W

    MDR report key: 1860136 · Received September 21, 2010

    Report

    Report Number
    1221336-2010-00005
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 21, 2010
    Manufacturer
    INTEGRA LUXTEC
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAMP ON THIS LIGHT SOURCE IS NOT ILLUMINATED UNLESS A FIBEROPTIC CABLE IS INSERTED. THE BIOMED WAS NOT ABLE TO CONFIRM IF A CABLE WAS IN THE LIGHT SOURCE. THE LIGHT SOURCE WAS RETURNED TO LUXTEC FOR INVESTIGATION AND WAS EVALUATED BY THE REPAIR DEPT, QUALITY DEPT AND OPERATIONS DEPT AT LUXTEC. EVAL SHOWED SIGNIFICANT CHARRING DUE TO HIGH TEMPS ON THE UNDERSIDE OF THE POWER SUPPLY WHERE THE PRINTED CIRCUIT BOARD AND A SHEET OF PLASTIC INSULATION HAD LOCALIZED MELTING. THE POWER SUPPLY WAS NO LONGER OPERATIONAL. HOWEVER, THE FUSES IN THE POWER SUPPLY WERE INTACT AS WERE THE FUSES IN THE POWER ENTRY MODULE OF THE LIGHT SOURCE. IT SHOULD BE NOTED THAT THE POWER SUPPLY HAS AN INDEPENDENT THERMAL SWITCH WHICH WILL SHUT DOWN THE POWER SUPPLY WHEN ITS TEMP EXCEEDS 90 DEGREES C. AT LUXTEC, THE LAMP WAS REMOVED FROM THE FAILED LIGHT SOURCE. ON THE BACK OF THE UNIT IT WAS NOTED THAT THE LAMP WAS REPLACED ON (B)(4) 2010. THE REPLACEMENT LAMP HAS A LABEL FROM "PRODUCTS FOR MEDICINE". NON LUXTEC LAMPS ARE NOT USED IN THE LX300. THIS COULD HAVE BEEN A CONTRIBUTING FACTOR IN THE FAILURE. IT WAS ALSO OBSERVED THAT THE REAR PANEL HAD SIGNIFICANT DAMAGE, A RESULT OF AN UNK EVENT. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED NO SERVICE HAS BEEN DONE BY LUXTEC. THE POWER SUPPLY FAILURE MAY HAVE OCCURRED DUE TO A FAILED CAPACITOR WHICH SHOWED THE MOST DAMAGE, HOWEVER, OTHER ELECTRICAL COMPONENTS COULD HAVE INITIATED THE REACTION. LITERATURE REPORTS THAT PREMATURE FAILURE OF CAPACITORS CAN OCCUR BECAUSE OF MECHANICAL SHOCK. ADDITIONALLY, PREMATURE CAPACITOR FAILURE CAN BE DUE TO OPERATING THE UNIT IN A HOTTER THAN NORMAL ENVIRONMENT OR BLOCKING AIR VENT IN THE CHASSIS. OPERATING THE LIGHT SOURCE AT HIGHER TEMP HAS THE EFFECT OF ACCELERATING THE AGE OF COMPONENTS AND DECREASES THEIR USEFUL LIFE. ACCORDING TO THE COMPLAINT RECORD, SINCE JUNE 2009, TWO LX300 LIGHT SOURCES HAVE FAILED WITH A SIMILAR FAILURE MODE OF A LOUD NOISE AND THE SMELL OF SMOKE. BASED ON THIS, THE RATE OF OCCURRENCE IS CONSIDERED LOW. THIS LX300 POWER SUPPLY FAILURE WAS PROBABLY DUE TO A BLOWN CAPACITOR. THE LX300 POWER SUPPLY GENERALLY HAS BEEN DEPENDABLE WITH LOW FAILURE RATE. ALTHOUGH POWER SUPPLIES HAVE FAILED IN THE PAST RESULTING IN SMOKE, NO LX300 LIGHT SOURCE FAILURES RESULTING IN FLAMES OR FIRE HAVE OCCURRED. THE LIGHT SOURCE COMPONENTS ARE MADE TO STRICT FLAMMABILITY GUIDELINES FOR MEDICAL EQUIPMENT. BASED ON THE REPORTED INFO AND THE INVESTIGATION RESULTS PROVIDED, INTEGRA CONSIDERS THIS COMPLAINT CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE INTEGRA REP RECEIVED A COMPLAINT FROM THE CUSTOMER THAT ON (B)(6) 2010, THE LX300 "POWER SUPPLY HAD SOME KIND OF ISSUE AND CAUSED THE UNIT TO SMOKE AND SPARK SIGNIFICANTLY. THE UNIT DID NOT COME IN CONTACT OR AFFECT ANY PT. IT DID SMOKE TO A DEGREE THAT IT FILLED UP THE ROOM WITH A BURNT PLASTIC ODOR, AND SMOKE WAS EVIDENT. "THE BIOMED REPORTED ON (B)(4) 2010 THAT THE LIGHT SOURCE WAS IN THE OPERATING ROOM AND PLUGGED IN AT THE TIME OF THE INCIDENT, BUT NO SURGERY WAS TAKING PLACE. NO PT CONTACT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LX300, TURRET 300W NA KOG INTEGRA LUXTEC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1