BEUDAMED
    FDA Adverse Event Other Summary report: N

    FO LIGHT CABLE AUTOCLAV

    MDR report key: 1466303 · Received September 2, 2009

    Report

    Report Number
    2523190-2009-00002
    Event Type
    Other
    Date Received
    September 2, 2009
    Report Date
    September 2, 2009
    Manufacturer
    MILTEX, INC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED FOR MEDICAL FACILITY THAT THE PT WAS BURNED BY THE FIBER OPTIC CABLE. THE CUSTOMER REPORTED THAT THE LIGHT SOURCE WAS AT THE HIGHEST SETTING (LINVATEK MODEL # LIS8430, SERIAL # (B)(4)). A RETRACTOR (SNOWDEN PENCER # 88-1086) WAS USED WITH THE FIBER OPTIC CABLE. THE FIBER OPTIC CABLE WAS NOT REMOVED FROM THE RETRACTOR, AND WAS LEFT ON THE OPERATIVE FIELD AFTER USE. THE CUSTOMER REPORTS THAT THE CONNECTING "SWIVEL END" (INSTRUMENT COUPLER) WAS WARM. THERE WERE TWO "DIME SIZE" BURNS - TO THE PT. THE WOUND WAS TREATED WITH SILVADENE BURN CREAM AND A TEGADERM BANDAGE. NO FURTHER TREATMENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FO LIGHT CABLE AUTOCLAV M5 - GENERAL SURGERY GCJ MILTEX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1