BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3781017 · Received April 30, 2014

    Report

    Report Number
    2937094-2014-00324
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    December 18, 2013
    Report Date
    March 20, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATION: FAILURE ANALYSIS FOR FIBER (B)(4): THE GLASS CAP/FIBER SHOWS A CIRCUMFERENTIAL FRACTURE DISTAL TO FIBER/CAP FUSION ZONE AT THE BEVEL EDGE; THE FIBER PROXIMAL TO FRACTURE CAN ROTATE INDEPENDENTLY OF METAL CAP; THE METAL CAP EXHIBITS SEVERE CHAR; THE GLASS CAP EXHIBITS SEVERE DEVITRIFICATION AT THE OUTPUT WINDOW; THE DISTAL END OF THE GLASS CAP/FIBER IS DETACHED AND NOT RETURNED. BASED ON THE ANALYSIS RESULTS, 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 LIMITING THE PERFORMANCE OF THE FIBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE BEGINNING OF THE PROCEDURE THE TIP OF FIBER OF THE FIRST FIBER USED WAS CRACKED AT 211,930 JOULES. THE FIBER WAS EXCHANGED. THE SECOND FIBER USED DURING THE CASE EXPIRED AT 200,010 JOULES. THE FIBER WAS EXCHANGED. THE THIRD FIBER WOULD NOT ¿SEAT¿ - MISSING GOLD RING INSIDE CONNECTOR, 0 JOULES. THE FIBER WAS EXCHANGED. THE PROCEDURE WAS COMPLETED USING THE FOURTH FIBER. PATIENT OR USER OUTCOME - NO INJURY TO THE PATIENT. GAND VOLUME: 200 ML. TIME EXPENDED 2ND FIBER: 45:45 MINUTES. THIS REPORT IS FOR THE SECOND FIBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260469 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 336A

    Patients

    Seq Age Sex Outcome Treatment
    1