BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 4122658 · Received September 26, 2014

    Report

    Report Number
    2937094-2014-00872
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    January 30, 2014
    Report Date
    September 4, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: FAILURE ANALYSIS FOR FIBER (B)(4): THE GLASS CAP AND METAL CAP ARE DETACHED BUT A STILL LOOSELY CONNECTED TO THE OUTER LOW TUBING; THE FIBER SHOWS A CIRCUMFERENTIAL FRACTURE PROXIMAL TO FIBER/CAP FUSION ZONE AT THE METAL CAP OPEN END; THE OUTER FLOW TUBING IS BEND AND TORN AT THE LOCATION OF THE FRACTURE; THE OUTER FLOW TUBING EXHIBITS CONTAMINATION, LIKELY BIOLOGIC, AT THE LOCATION OF THE FRACTURE; THE GLASS CAP EXHIBITS MILD DEVITRIFICATION AT THE OUTPUT WINDOW. BASED ON THE ANALYSIS ABOVE, THE POTENTIAL FOR FORWARD FIRING MAY EXIST. PROBABLE ROOT CAUSE: BASED ON THE PRODUCT ANALYSIS RESULTS, THE PROBABLE ROOT CAUSE OF THE FAILURE IS: HEAT ACCUMULATION. CAP WEAR WAS ACCELERATED DUE TO ANATOMICAL/PROCEDURAL FACTORS (TISSUE CONTACT AND TECHNIQUE) ENCOUNTERED DURING THE PROCEDURE WHICH WOULD LIMIT THE PERFORMANCE OF THE FIBER.

    Additional Manufacturer Narrative · 1

    (B)(4) (NO CODE AVAILABLE) REFERS TO FORWARD-FIRING OF THE SIDE-FIRING SURGICAL FIBER; A CODE REQUEST HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE SIDE-FIRING SURGICAL FIBER DURING A PROSTATE PROCEDURE, THE "FIBER WAS OBSERVED TO BE FORWARD-FIRING - TIP DAMAGED" @ 91,147 JOULES OF USE AND 18:12 MINUTES. THE PROCEDURE WAS COMPLETED USING A SECOND SURGICAL FIBER. PATIENT OUTCOME: "NO DAMAGES TO THE PATIENT" - THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601419 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 251A

    Patients

    Seq Age Sex Outcome Treatment
    1