BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSIVA 1000

    MDR report key: 1964461 · Received January 6, 2011

    Report

    Report Number
    1964461
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 19, 2010
    Report Date
    January 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN WAS USING THE VERSIVA 1000 LASER FIBER TO BREAK UP A BLADDER STONE. IT WAS NOTED THAT THE TIP OF THE FIBER BROKE OFF IN THE PATIENT'S BLADDER. THE MD USED GRASPING FORCEPS AND IRRIGATED THE BLADDER WITH ELLIK EVACUATORS AND COULD NOT FIND THE TIP IN THE BLADDER AFTER THAT TREATMENT. HE DID NOT FIND THE TIP FOR INSPECTION BUT HE SUSPECTED THAT THE TIP WAS FLUSHED OUT. MD NOTE FROM THE PROCEDURE: "THE TIP OF THE LASER FIBER ACTUALLY FRACTURED AFTER JUST BEGINNING THE SHOCKWAVE LITHOTRIPSY AND WAS RETRIEVED TO THE BEST OF MY ABILITY AND I BELIEVE WAS RETRIEVED SUCCESSFULLY AS I DESCRIBED. THIS WAS A SUCCESSFUL CYSTOLITHOTRIPSY." THE PATIENT WENT TO RECOVERY ROOM IN STABLE CONDITION AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSIVA 1000 LASER FIBER GEX BOSTON SCIENTIFIC CORPORATION * 1ML0081701

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR