BEUDAMED
    FDA Adverse Event Other Summary report: N

    INFRATOME 30 DEGREE

    MDR report key: 759178 · Received September 11, 2006

    Report

    Report Number
    1720381-2005-00005
    Event Type
    Other
    Date Received
    September 11, 2006
    Date of Event
    June 30, 2005
    Report Date
    September 11, 2006
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: PER INVESTIGATION BY LUMENIS AND THE CUSTOMER, THE ROOT CAUSE OF THE INCIDENT WAS USER ERROR. THE PHYSICIAN DID NOT USE THE TROCAR TO ADVANCE THE FIBER, THE PHYSICIAN JAMMED THE FIBER AGAINST THE TISSUE AND BONE, CAUSING THE FIBER TO ERODE (RATHER THAN TO BREAK) AND LEAVE VERY SMALL DEBRIS WITHIN THE JOINT. THE PHYSICIAN WAS ADVISED BY LUMENIS REGARDING RECOMMENDED TECHNIQUE. PHYSICIAN DEMONSTRATED IMPROVED TECHNIQUE WITHOUT ANY PROBLEMS DURING THE CASE OBSERVED BY LUMENIS. THE CUSTOMER RETAINED THE SUSPECT INFRATOME FIBER AND SHOWED IT TO THE LUMENIS REPRESENTATIVE, BUT DECLINED TO RETURN THE FIBER TO LUMENIS FOR EVALUATION. CUSTOMER HAD A LUMENIS TRAINING TWO MONTHS PRIOR TO THE INCIDENT; CUSTOMER DELAYED THE START OF THE TRAINING BY 8 HOURS, AND ONLY SOME STAFF PARTICIPATED IN THE HANDS-ON SESSION REGARDING FIBER HANDLING. AFTER THE INCIDENT LUMENIS OFFERED TO SEND THE LUMENIS TRAINER BACK TO THE CUSTOMER LOCATION ON A COMPLIMENTARY BASIS, AND THE CUSTOMER DECLINED. THE ASSOCIATED POWERSUITE SYSTEM WAS EVALUATED BY LUMENIS ON 06/21/2005 (5 DAYS PRIOR TO THE REPORTED INCIDENT), THE LUMENIS CUSTOMER ENGINEER VERIFIED SYSTEM OPERATION AS NORMAL, CALIBRATION AND ALIGNMENT CORRECT.

    Description of Event or Problem · 1

    DURING AN ARTHROSCOPY PROCEDURE TO THE RIGHT KNEE, THE FIBER TIP BROKE OFF INSIDE THE PATIENT'S KNEE. PER THE CUSTOMER, THE FIBER FRAGMENTS WERE TOO SMALL TO BE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER. NO INJURY WAS REPORTED. THE PHYSICIAN WAS AN ORTHOPEDIC SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFRATOME 30 DEGREE FIBERS GEX LUMENIS, INC. 0638-804-01 060998

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other REQUESTED AND NOT PROVIDED