BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS GREENLIGHT HPS FIBER

    MDR report key: 5814645 · Received July 21, 2016

    Report

    Report Number
    2937094-2016-00764
    Event Type
    Malfunction
    Date Received
    July 21, 2016
    Date of Event
    June 17, 2016
    Report Date
    June 28, 2016
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: FAILURE ANALYSIS FOR FIBER 0010-2093-541J-(B)(4): THE FIBER/GLASS CAP IS FRACTURED AT THE UV GLUE ZONE; THE FIBER/GLASS CAP DISTAL PART IS DETACHED AND PARTIALLY RETURNED; THE TIP OF THE FIBER/GLASS CAP IS NOT RETURNED; THE GLASS CAP AND FIBER CORE ARE NOT ADHERED; THE HEAT SHRINK TUBING EXHIBITS SIGNS OF ABRASIONS AND MELTING; THE HEAT SHRINK TUBING OPEN END EXHIBITS SIGNS OF ABRASIONS AND MELTING, AND PARTIALLY ERASED RED OCTAGONAL SIGN AND BLUE ARROW INDICATOR; THE FIBER APPEARS BLACKENED AT AND NEAR THE HEAT SHRINK TUBING OPEN END, AND PARTIALLY ON THE FIBER CORE. BASED ON DEVICE ANALYSIS, THE POTENTIAL FOR FORWARD FIRING MAY EXIST. FIBER CARD ANALYSIS: USE DATE: (B)(6) 2016, USE TIME: 07:53:14 PM, JOULES USED: 66,130 JOULES. THE FIBER CARD IS EXPIRED ¿ SOFT JOULE LIMIT HAS BEEN REACHED. JOULES COUNT DOES NOT MATCH WARRANTY FORM INFORMATION. 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 SURGICAL PROCEDURE AT 128,000 JOULES OF USE AND 35 MINUTES, ¿FIBER DAMAGED AT TIP; TIP SEPARATION OCCURRED IN THE PATIENT BODY AND SNARING IT OUT SAFELY¿. THE FIBER WAS EXCHANGED AND THE SECOND FIBER EXHIBITED SAME ISSUE AT 62,000 JOULES AND 4 MINUTES. THE FIBER TIPS (CAPS) OF BOTH FIBERS WERE CLEANED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING THIRD FIBER AT 420,000 JOULES AND ELECTRIC CAUTERY. MAXIMUM LASER WATTAGE SET FOR PROCEDURE WAS 100W. PATIENT OUTCOME "FINE". NO INJURY TO THE PATIENT WAS REPORTED. THIS REPORT IS FOR SECOND FIBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465582 AMS GREENLIGHT HPS FIBER POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2093 541J

    Patients

    Seq Age Sex Outcome Treatment
    1