BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUMAXTM SINGLE USE HOLMIUM LASER FIBER

    MDR report key: 3252104 · Received July 29, 2013

    Report

    Report Number
    3005099803-2013-07730
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 4, 2013
    Report Date
    July 5, 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

    REPORTED EVENT OF FIBER BROKE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACCUMAX LASER FIBER WAS USED DURING A FLEXIBLE URETEROSCOPY PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DISTAL TIP OF THE FIBER BROKE INSIDE THE PATIENT BUT WAS NOT DETACHED. THE TIP WAS STRIPPED AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE WITHOUT ISSUE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352568 ACCUMAXTM SINGLE USE HOLMIUM LASER FIBER POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC - MARLBOROUGH M0068404012 ML00001148

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR