BEUDAMED
    FDA Adverse Event Other Summary report: N

    CHROMOPHARE

    MDR report key: 2401777 · Received December 30, 2011

    Report

    Report Number
    1220685-2011-00008
    Event Type
    Other
    Date Received
    December 30, 2011
    Date of Event
    December 19, 2011
    Report Date
    December 28, 2011
    Manufacturer
    BERCHTOLD CORP.
    Product Code
    FSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIGHTS WERE EVALUATED BY A BERCHTOLD CORP SVC TECH ON (B)(4) 2011, AT THE LOCATION WHERE THE INCIDENT OCCURRED. THE LAMPHEADS WERE INSP AND THE LIGHT INTENSITY IN LUX WAS MEASURED FOR EACH LAMPHEAD. THE SPEC FOR INTENSITY IS 160 KLUX. THE INTENSITY FOR LAMPHEAD (B)(4) (THIS MDR) WAS MEASURED TO BE 169.2 KLUX, AND THE INTENSITY FOR LAMPHEAD (B)(4) (MDR 1220685-2011-00009) WAS MEASURED TO BE 159 KLUX. THE INTENSITY WAS ADJUSTED TO BE WITHIN SPEC. THE OPERATORS MANUAL FOR THIS LIGHT SYS CONTAINS THE FOLLOWING SAFETY STATEMENTS FOR THE OPERATOR: THE OVERLAY OF THE LIGHT FIELDS CAN CAUSE AN INCREASE IN HEAT GENERATION. IN THE CASE OF A COMBINATION LIGHT THE LAMP HOUSINGS ARE POSITIONED SO THAT THE LIGHT FIELDS OF BOTH LIGHTS ARE COINCIDENT, THE OPERATOR SHOULD CONSIDER THE FOLLOWING: THE LIGHT'S ADJUSTMENT TO MAXIMUM ILLUMINATION CAUSES AN INCREASED DESICCATION OF THE TISSUE. THE OPERATORS MANUAL AND THE SVC MANUAL SPECIFY THAT MAINTENANCE NEEDS TO BE PERFORMED YEARLY AGAINST A CHECKLIST, AND THE ITEMS ON THE CHECKLIST INCLUDE INTENSITY OF ILLUMINATION AND BULB VOLTAGE. BERCHTOLD DOES NOT HAVE A MAINTENANCE CONTRACT WITH THIS FACILITY AND COULD NOT OBTAIN ANY INFO THAT SUPPORTS THE LIGHTS WERE MAINTAINED IN ACCORDANCE WITH MFR'S INSTRUCTIONS. THE SAFETY STATEMENTS WERE BROUGHT TO THE ATTENTION OF THE USERS FOR FUTURE REFERENCE.

    Description of Event or Problem · 1

    INITIAL REPORTS WERE THAT THE SKIN AROUND THE SURGICAL SITE ON A FEMALE CHILD WAS HOT AND DARKER IN COLOR THAN THE SURROUNDING SKIN, AND IS POSSIBLY BURNED. THIS OCCURRED AFTER A 3 HOUR LONG UROLOGY PROCEDURE. IT WAS ALSO REPORTED THAT THE LIGHT FROM TWO LAMPHEADS AT FULL INTENSITY WERE FOCUSED ON THE SURGICAL AREA. TWO DAYS AFTER THE PROCEDURE, IT WAS REPORTED THAT THERE WAS NO DISCOLORATION, MARKS, OR ISSUES ON THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHROMOPHARE SURGICAL LIGHT FSY BERCHTOLD CORP. E655

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other