BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 8029106 · Received November 1, 2018

    Report

    Report Number
    2937094-2018-60067
    Event Type
    Malfunction
    Date Received
    November 1, 2018
    Date of Event
    September 28, 2018
    Report Date
    January 7, 2019
    Manufacturer
    AMERICAN MEDICAL SYSEMS, INC
    Product Code
    GEX
    UDI-DI
    00878953005515
    PMA / PMN Number
    K120870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MANUFACTURER UPDATED. EVALUATION CODES ADDED. THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICES MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. ANALYSIS OF THE DEVICE REVEALED THE GLASS CAP HAS A CIRCUMFERENTIAL FRACTURE ON THE DISTAL SIDE OF FIBER/CAP FUSION ZONE AT THE BEVEL EDGE. THE FIBER PROXIMAL TO FRACTURE CAN ROTATE INDEPENDENTLY OF OUTER FLOW TUBING. THE GLASS CAP EXHIBITS SEVERE DEVITRIFICATION AT OUTPUT WINDOW. THE METAL CAP EXHIBITS MODERATE DETRITUS ADHESION ON SURFACE. THE OUTER FLOW TUBING OPEN END EXHIBITS MINOR SCRATCH MARKS. BASED ON DEVICE ANALYSIS, THE POTENTIAL FOR FORWARD FIRING MAY EXIST. IT IS PROBABLE THAT 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. THE IDENTIFIED ISSUES NOTED ABOVE MAY ACTIVATE THE FIBERLIFE FUNCTION WHICH WOULD MODULATE THE POWER SHOWING A PULSING BEAM OR SYSTEM WOULD BE PLACED INTO STANDBY MODE. AN EVALUATION CONCLUSION CODE OF KNOWN INHERENT RISK OF THE DEVICE WAS ASSIGNED TO THIS INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE AT 177,580J AND 12 MINS OF USE, THE FIBER BROKE. THE FIBER TIP (CAP) WAS NOT CLEANED DURING THE PROCEDURE THE PROCEDURE WAS COMPLETED USING RESECTION TECHNIQUE. NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING PHOTO SELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE, THE FIBER BROKE. THE PROCEDURE WAS COMPLETED USING RESECTION TECHNIQUE. NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE AT 177,580J AND 12 MINS OF USE, THE FIBER BROKE. THE FIBER TIP (CAP) WAS NOT CLEANED DURING THE PROCEDURE THE PROCEDURE WAS COMPLETED USING RESECTION TECHNIQUE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869684 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSEMS, INC 0010-2400 0022045292 00878953005515

    Patients

    Seq Age Sex Outcome Treatment
    1