BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENDOSTAT FIBER

    MDR report key: 1770280 · Received July 20, 2010

    Report

    Report Number
    2937094-2010-00006
    Event Type
    Other
    Date Received
    July 20, 2010
    Date of Event
    June 24, 2010
    Report Date
    June 25, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FIBER HAS NOT YET RETURNED FOR EVALUATION. THE ENDOSTAT FIBER WAS USED WITH THE (B) (6) LASER SYSTEM, P/N 0010-8124. (B) (4) . THE LASER SYSTEM IS TO BE CHECKED BY AMS SERVICE. THE FIBER IS TO RETURN FOR EVALUATION. A FOLLOW UP MEDWATCH REPORT WILL GIVE EVALUATIONS OF LASER AND FIBER. THE PROCEDURE PERFORMED WAS A PHARYNGOSCOPY. INVESTIGATION FOUND THAT THE NURSE DID NOT STRIP THE FIBER BEFORE USE WITH THE HANDPIECE. AS SOON AS THE SURGEON USED THE LASER IN THE LARYNX, A SMALL FLAME WAS PRODUCED AT THE END OF THE UNSTRIPPED FIBER. THE PHYSICIAN HAS REPORTED THERE WAS NO ADVERSE EFFECT ON THE PT AND THAT THE PT IS FINE AND NO COMPLICATIONS REPORTED. LABELING IS SUFFICIENT: AMS DISPOSABLE ENDOSTAT FIBER PRODUCT INSERT, P/N 0114-0820, REV. R GIVES SPECIFIC INSTRUCTIONS FOR USE OF ENDOSTAT FIBERS: "4. STRIP THE FIBER TIP WITH THE APPROPRIATE STRIPPER AFTER INSERTION INTO THE CURVED OR ANGLED HANDPIECE, AND BEFORE INSERTION INTO A STRAIGHT HANDPIECE, ENDOSCOPE OR LAPAROSTAT." AND "WARNING: ANY CHIPS OR DEBRIS ON THE DISTAL TIP CAN CAUSE THE TIP TO FLARE." AND "A DULL STRIPPER CAN BE THE MOST LIKELY CAUSE OF DISTAL TIP FLARE."

    Description of Event or Problem · 1

    FACILITY REPORTED WHILE USING THE (B) (6) DURING SURGERY, A FLAME EMITTED FROM THE INSTRUMENT AND BURNED THE PT'S VOCAL CORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSTAT FIBER FIBER GEX AMERICAN MEDICAL SYSTEMS NA 947

    Patients

    Seq Age Sex Outcome Treatment
    1 Other