BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 3841548 · Received May 30, 2014

    Report

    Report Number
    2937094-2014-00426
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    March 25, 2014
    Report Date
    May 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FORWARD FIRING OF THE SIDE FIRING SURGICAL FIBER; A CODE REQUEST HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: FAILURE ANALYSIS FOR FIBER (B)(4): THE FIBER CAP REMAINS ATTACHED AND EXHIBITS A DRILLED THROUGH CONDITION; THE GLASS CAP EXHIBITS MODERATE DETRITUS ADHESION; THERE IS SOME WHITE UNKNOWN SUBSTANCE NOTED INSIDE THE FIBER CAP TIP; THE BEVEL SECTION IS MELTED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, THE FIBER WAS OBSERVED TO FORWARD FIBER @ 30,000 JOULES. THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER. THERE WAS ¿NO ADVERSE OUTCOME FOR PATIENT.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318388 GREENLIGHT HPS BPH FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2090 220H

    Patients

    Seq Age Sex Outcome Treatment
    1