BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODEL 550-E1

    MDR report key: 86170 · Received April 18, 1997

    Report

    Report Number
    2950727-1997-00001
    Event Type
    Malfunction
    Date Received
    April 18, 1997
    Date of Event
    March 17, 1997
    Report Date
    April 16, 1997
    Manufacturer
    ECLIPSE SURGICAL TECHNOLOGIES, INC.
    Product Code
    LNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A DRAPE FIRE OCCURRED DURING A UROLOGY PROCEDURE WITH THE MODEL 550-E1 FIBER. IN THE OPINION OF THE NURSE, THE FIBER HAD A "WEAK POINT" (MOST LIKELY FROM SOMETHING HEAVY PRESSED AGAINST OR PLACED ON TOP OF THE UNIT), CAUSED A CREASE IN THE FIBER, THEN WHEN THE FIBER WAS USED CLINICAL, THE FIBER FRACTURED CAUSING A DRAPE FIRE (PROXIMAL TO THE PT'S LEG). THE FIRE WAS IMMEDIATELY EXTINGUISED AND NO INJURY TO THE PT OR THE STAFF WAS REPORTED. AN EVALUATION OF THE RETURNED FIBER SHOWED THAT THE FIBER WAS MOST LIKELY IMPROPERLY CLAMPED TO THE DRAPE WITH A HEMOSTAT. IT APPEARED THAT THE USER HAD DIRECTLY CLAMPED THE HEMOSTAT ONTO THE FIBER, WHICH CAUSED THE FIBER TO BREAK, MISDIRECTING THE LASER ENERGY INTO THE DRAPE AT THE POINT OF BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL 550-E1 FIBER OPTIC DELIVERY SYSTEM LNK ECLIPSE SURGICAL TECHNOLOGIES, INC. 550-E1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other