BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 7307264 · Received March 1, 2018

    Report

    Report Number
    2937094-2018-00207
    Event Type
    Malfunction
    Date Received
    March 1, 2018
    Date of Event
    February 6, 2018
    Report Date
    February 7, 2018
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    UDI-DI
    00878953004709
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: FAILURE ANALYSIS FOR FIBER (B)(4): THE GLASS FIBER CORE EXHIBITS A CIRCUMFERENTIAL FRACTURE PROXIMAL TO FUSION ZONE AT THE BEVEL EDGE; THE FIBER CAP EXHIBITS SIGNS OF MELTING WHICH FORMED A HOLE FROM THE SURFACE TO THE BEVEL EDGE; THERE IS SOME WHITE UNKNOWN SUBSTANCE NOTED INSIDE THE DISTAL END OF FIBER CAP; THE GLASS CAP EXHIBITS SEVERE DEVITRIFICATION AT THE OUTPUT AREA, AND DETRITUS ADHESION AROUND OUTPUT AREA; THE FIBER WAS TESTED WITH HENE LASER FIXTURE, THE AIM BEAM IS PRESENT AT THE OUTPUT WINDOW AND BREAK LOCATION. BASED ON THE DEVICE ANALYSIS, THE POTENTIAL FOR FORWARD FIRING MAY EXIST. PROBABLE ROOT CAUSE: BASED ON THE DEVICE ANALYSIS, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT 16 MINUTES, 112,000 JOULES WHILE USING THE SURGICAL FIBER DURING A PROSTATE PROCEDURE, THE FIBER WAS BROKEN/DAMAGED. THE FIBER WAS REPLACED AND THE PROCEDURE COMPLETED USING A SECOND SURGICAL FIBER. PATIENT OUTCOME: "NO INJURY TO THE PATIENT". THE WAS NO INJURY TO THE PATIENT OR STAFF REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149304 GREENLIGHT HPS BPH FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2090 741H 00878953004709

    Patients

    Seq Age Sex Outcome Treatment
    1