BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALM

    MDR report key: 479217 · Received August 18, 2003

    Report

    Report Number
    9710053-2003-00002
    Event Type
    Other
    Date Received
    August 18, 2003
    Date of Event
    July 10, 2003
    Report Date
    August 15, 2003
    Manufacturer
    ALM
    Product Code
    FSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A SURGICAL OPERATION, A PORTION OF A GLASS HEAT ABSORPTION FILTER BROKE AWAY FROM ITS SUBASSEMBLY, AND DROPPED OUT OF THE OPTICAL PATH. THE PIECE(S) WERE CONTAINED WITHIN THE LIGHTHEAD ASSEMBLY. THE SURGERY SESSION CONTINUED FOR APPROXIMATELY 3.5 HOURS WITH THIS BROKEN FILTER SUBASSEMBLY THAT ENCOMPASSES THE LIGHT SOURCE. THE HOSPTIAL STAFF NOTED THAT THE PATIENT'S SKIN AS PETECHIAE AND HAD A CIRCULAR BLISTERING TYPE BURN, ABOUT THE SIZE OF A SILVER DOLLAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALM SURGICAL LIGHT FSY ALM PRX4401 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other