BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 6967014 · Received October 20, 2017

    Report

    Report Number
    2937094-2017-00919
    Event Type
    Malfunction
    Date Received
    October 20, 2017
    Date of Event
    September 22, 2017
    Report Date
    September 25, 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
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: FAILURE ANALYSIS FOR FIBER 0010-2090-721H-(B)(4): THE GLASS FIBER CORE EXHIBITS A CIRCUMFERENTIAL FRACTURE PROXIMAL TO FUSION ZONE OF THE BEVEL EDGE AND ANOTHER LOCATED ON THE BEVEL EDGE; THERE IS A 1MM GAP CREATED BY THE PROXIMAL FRACTURE; THE GLASS CAP EXHIBITS SEVERE DEVITRIFICATION AT THE OUTPUT AREA, AND DETRITUS ADHESION AROUND OUTPUT AREA. 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 BPH SURGICAL PROCEDURE AT 20,275 JOULES OF USE AND 8 MINUTES, ¿FAULTY LASER SHOT (UNCONTROLLABLE DIRECTION)¿ WAS NOTED. THE FIBER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER. PATIENT OUTCOME ¿OK¿ REPORTED. NO INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745653 GREENLIGHT HPS BPH FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2090 721H 00878953004709

    Patients

    Seq Age Sex Outcome Treatment
    1