BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORNIER HOLMIUM LASER FIBER

    MDR report key: 2160328 · Received May 16, 2011

    Report

    Report Number
    1037955-2011-00008
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Report Date
    May 16, 2011
    Manufacturer
    DORNIER MEDTECH AMERICA, INC.
    Product Code
    GEX
    PMA / PMN Number
    022544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THIS COMPLAINT PRODUCT INDICATES THAT THE FIBER BREAK LIKELY OCCURRED DUE TO A SEVERE BEND BEYOND THE FIBER MINIMUM BEND RADIUS OF 7MM WHILE UNDER LASER FIRE. THIS BEND LIKELY OCCURRED FROM THE APPLICATION OF EXTERNAL MECHANICAL FORCE TO THE FIBER DIRECTLY BEHIND THE REAR STAINLESS STEEL SMA PIN CAUSING THE FIBER TO BE BENT BEYOND THE MINIMUM BEND RADIUS WHILE THE FIBER WAS UNDER FIRE BY A LASER. IT WAS FURTHER HYPOTHESIZED THAT THE OPERATING ROOM TECH WAS BURNED ON HER ABDOMEN BY THE BREAKING POINT OF THE FIBER BECAUSE HER ABDOMEN MAY HAVE ACTED AS THE EXTERNAL MECHANICAL FORCE WHICH WAS APPLIED TO THE FIBER WHILE UNDER LASER FIRE CAUSING THE BREAK (THE OPERATING ROOM TECH LEANED OVER THE LASER WITH HER ABDOMEN HITTING THE FIBER WHILE UNDER FIRE BENDING THE FIBER CAUSING THE BREAK.) THIS SPECULATION IS SUPPORTED BY OBJECTIVE EVIDENCE THAT THE SMA CONNECTION POINT ON A LASER IS POSITIONED AT ABDOMEN HEIGHT ON MOST HOLMIUM LASERS AND THAT DIRECT TISSUE BURNS FROM 270 UM DORNIER FIBERS AT THE MAXIMUM FIBER CAPABILITY OF 20 WATTS CAN ONLY OCCUR WITHIN A RANGE OF ONE TO TWO INCHES OF THE LASER ENERGY EXITING THE TIP OF A FIBER, OR IN THIS CASE THE BREAKING POINT OF THE FIBER. BURN TESTING FOR THIS DISTANCE DETERMINATION WAS PERFORMED WITH CALIBRATED TEST AND MEASUREMENT EQUIPMENT. THIS FIBER BEND (BREAK) COULD ONLY HAVE OCCURRED DURING FIBER USE BY THE END USER AS SUCH AN EVIDENT BEND (BREAK) WOULD HAVE FAILED POWER TESTING DURING FIBER MANUFACTURING IN ADDITION TO BEING CLEARLY NOTED BY FIBER PRODUCTION PERSONNEL AS AN ABNORMAL DEFECT. THIS FIBER BREAK APPEARS TO BE FROM A USER HANDLING ISSUE.

    Description of Event or Problem · 1

    FIBER BROKE AT SMA CONNECTOR TO LASER. OPERATING ROOM TECH'S GOWN AND ABDOMEN WAS BURNT. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DORNIER HOLMIUM LASER FIBER LASER FIBER GEX DORNIER MEDTECH AMERICA, INC. DUR270D F0411A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other