BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 4101136 · Received September 19, 2014

    Report

    Report Number
    2937094-2014-00854
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    December 29, 2012
    Report Date
    September 5, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: FAILURE ANALYSIS FOR FIBER (B)(4): THE FIBER WAS RETURNED IN 2 SECTIONS; THE PROXIMAL SECTION IS BROKEN 3 CM FROM DISTAL END; THE FIBER IS BLACKENED AT THE FRACTURE AND THE HEAT SHRINK TUBE IS SEVERELY MELTED; THE SECOND SECTION DISTAL TO THE FIRST SECTION IS 3CM LONG AND INCLUDES THE GLASS CAP; THE FIBER CAP EXHIBITS A DRILLED THROUGH CONDITION; THE FIBER CAP EXHIBITS SEVERE DETRITUS CHAR; THE FIBER IS BLACKENED ALL THE WAY; THE HEAT SHRINK TUBING IS MELTED AND/OR MISSING; THE FIBER INSIDE THE CAP EXHIBITS CONTAMINATION, LIKELY BIOLOGIC. BASED ON THE DEVICE ANALYSIS, 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 CAP "DETACHED". THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER. UNKNOWN IF CAP DETACHED INSIDE PATIENT OR IF RETRIEVAL WAS REQUIRED. NO FURTHER INFORMATION WAS AVAILABLE. PATIENT OUTCOME: "NO INJURY TO THE PATIENT REPORTED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585194 GREENLIGHT HPS BPH FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2090 225H

    Patients

    Seq Age Sex Outcome Treatment
    1