BEUDAMED
    FDA Adverse Event Other Summary report: N

    CHROMOPHARE

    MDR report key: 2818430 · Received October 19, 2012

    Report

    Report Number
    1220685-2012-00005
    Event Type
    Other
    Date Received
    October 19, 2012
    Date of Event
    September 14, 2012
    Report Date
    October 15, 2012
    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

    DURING THE PROCEDURE, TWO (2) LAMPHEADS WERE FOCUSED ON THE SURGICAL SIGHT AT MAXIMUM INTENSITY. THE LIGHTS WERE EVALUATED BY A BERCHTOLD CORP. SERVICE TECHNICIAN ON (B)(4) 2012, AT THE LOCATION WHERE THE INCIDENT OCCURRED. NO PROBLEMS WERE FOUND WITH THE LIGHTS. (ALSO SEE MDR 1220685-2012-00006). THE OPERATION MANUAL FOR THIS LIGHT SYSTEM 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.

    Description of Event or Problem · 1

    AFTER A ONE (1.5) HOUR DIAGNOSTIC LAPAROSCOPY, THERE WAS SKIN DISCOLORATION IN THE EXPOSED AREA NEAR THE PATIENT'S NAVEL WHERE THE EDGES OF THE SURGICAL DRAPES WERE PLACED.

    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 2 YR Other