BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUMAXTM SINGLE USE HOLMIUM LASER FIBER

    MDR report key: 3151628 · Received June 7, 2013

    Report

    Report Number
    3005099803-2013-04754
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    February 11, 2013
    Report Date
    May 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEX
    PMA / PMN Number
    K093691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE AS ANALYZED EVENT OF FIBER BROKEN WITHIN THE CONNECTOR. VISUAL ANALYSIS REVEALS THAT THE EXPOSED GLASS TIP MEASURES APPROXIMATELY 0.5 MM AND APPEARS USED. FUNCTIONAL EXAMINATION REVEALS THAT THE AIMING BEAM IS EXTREMELY WEAK INDICATING THAT THE FIBER IS BROKEN WITHIN THE CONNECTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING PREPARATION FOR THE PROCEDURE, AN ACCUMAX 200 LASER FIBER WAS TESTED AND THE AIMING BEAM WAS DIM. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITHOUT ANY COMPLICATIONS TO THE PATIENT. THE EVENT, AS REPORTED, DOES NOT CONSTITUTE A REPORTABLE MALFUNCTION; HOWEVER, THE RETURNED DEVICE REVEALED A REPORTABLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253129 ACCUMAXTM SINGLE USE HOLMIUM LASER FIBER POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC - MARLBOROUGH M0068404012 ML00001091

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR