BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOTOME RX39

    MDR report key: 3062786 · Received April 12, 2013

    Report

    Report Number
    MW5029764
    Event Type
    Injury
    Date Received
    April 12, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE DOING SPHINCTEROTOMY, WIRE ON SPHINCTEROTOME SPARKED AND THEN BROKE. DEVICE WAS REMOVED THROUGH THE SCOPE WITH NO APPARENT INJURY TO PT OR SCOPE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159010 AUTOTOME RX39 SPHINCTEROTOME KNS BOSTON SCIENTIFIC RX39 15625203

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention