BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATOME¿ XL

    MDR report key: 3052413 · Received April 11, 2013

    Report

    Report Number
    3005099803-2013-02613
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K930022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN A SPHINCTEROTOMY WAS ATTEMPTED, THERE WAS INSUFFICIENT ELECTRICAL CONDUCTIVITY TO PERFORM THE CUT. THE CUT WIRE ON THE TOME CHARRED INSTEAD OF CUT THE TISSUE. NO VISIBLE DAMAGE WAS NOTED TO THE DEVICE. THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS CLEVERCUT TOME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156522 ULTRATOME¿ XL SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00535920 15560905

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR