BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUMAXTM SINGLE USE HOLMIUM LASER FIBER

    MDR report key: 2123638 · Received June 14, 2011

    Report

    Report Number
    3005099803-2011-01943
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEX
    PMA / PMN Number
    K093691 
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL ANALYSIS OF THE RETURNED FIBER REVEALED A SMALL SECTION OF THE FIBER TIP WAS MISSING. THE FIBER WAS BROKEN 89 INCHES FROM THE BLACK STRAIN RELIEF. HANDLING DAMAGE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION DURING A LASER LITHOTRIPSY PROCEDURE, THE ACCUMAX 200 FIBER (BOX 5) CRACKED IN HALF OUTSIDE THE SCOPE. THE LASER SETTINGS ARE UNAVAILABLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 200 LASER FIBER.

    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 1ML0110802

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR HOLMIUM LASER