BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 7222555 · Received January 26, 2018

    Report

    Report Number
    2937094-2018-00100
    Event Type
    Malfunction
    Date Received
    January 26, 2018
    Date of Event
    December 12, 2017
    Report Date
    December 13, 2017
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: FAILURE ANALYSIS FOR FIBER 0010-2090-737H-(B)(4): THE GLASS FIBER CORE EXHIBITS A CIRCUMFERENTIAL FRACTURE PROXIMAL TO FUSION ZONE OF THE BEVEL EDGE; 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 DURING A BENIGN PROSTATIC HYPERPLASIA (BPH) SURGICAL PROCEDURE AT 26,500 JOULES OF USE AND 7 MINUTES, THE LASER FIBER DID NOT FIRE OR COAGULATE ANYMORE. THE FIBER TIP (CAP) WAS CLEANED DURING THE PROCEDURE. THE FIBER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED UTILIZING A SECOND FIBER. PATIENT OUTCOME: NO INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64768 GREENLIGHT HPS BPH FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2090 737H 00878953004709

    Patients

    Seq Age Sex Outcome Treatment
    1