BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUMAXTM SINGLE USE HOLMIUM LASER FIBER

    MDR report key: 2232365 · Received September 2, 2011

    Report

    Report Number
    3005099803-2011-02881
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    June 28, 2011
    Report Date
    August 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEX
    PMA / PMN Number
    K093691 
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL ANALYSIS OF THE RETURNED FIBER REVEALED THE AIMING BEAM IS NOT EXITING OUT OF THE DISTAL TIP OR ANY OTHER LOCATION ON THE BODY OF THE FIBER INDICATING THAT THE FIBER IS BROKEN WITHIN THE CONNECTOR. HANDLING DAMAGE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A LASER LITHOTRIPSY PROCEDURE USING AN ACCUMAX 200 FIBER, THE FIBER FAILED TO TRANSMIT ENERGY. THE HOLMIUM LASER WAS SET AT 16 WATTS. THE PROCEDURE WAS COMPLETED WITH A DORNIER DUR 270 FIBER WITHOUT ANY COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY "FINE" POST PROCEDURE. THE EVENT, AS REPORTED, DOES NOT CONSTITUTE AN MDR REPORTABLE MALFUNCTION; HOWEVER, INVESTIGATION OF THE RETURNED DEVICE REVEALED AN MDR REPORTABLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUMAXTM SINGLE USE HOLMIUM LASER FIBER POWERED LASER SURGICAL INSTRUMENT  GEX BOSTON SCIENTIFIC - MARLBOROUGH M0068404012 ML00000161

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR HOLMIUM LASER