BEUDAMED
    FDA Adverse Event Death Summary report: N

    OLYMPUS

    MDR report key: 193456 · Received October 23, 1998

    Report

    Report Number
    193456
    Event Type
    Death
    Date Received
    October 23, 1998
    Date of Event
    October 2, 1998
    Report Date
    October 13, 1998
    Manufacturer
    OLYMPUS AMERICA INC.
    Product Code
    LQC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: ENDOSCOPIC RETROGRADE CHOLANGIOGRAM WITH EXTENSION OF BILIARY SPHINCTEROTOMY AND EXTRACTION OF COMMON BILE DUCT STONE. EVENT: THE MECHANICAL LITHOTRIPTOR WAS PASSED INTO THE COMMON BILE DUCT. A FRAGMENT WAS ABLE TO BE BROKEN OFF. HOWEVER, THE CABLE BROKE WITHIN THE HANDLE OF THE BILIARY SPHINCTEROTOMY. WITH EXTREME DIFFICULTY, BOTH THE STONE AND BASKET WERE ABLE TO BE FINALLY REMOVED. HOWEVER, BECAUSE OF MARKED EDEMA THE PROCEDURE WAS STOPPED. PT LATER DEVELOPED COMPLICATIONS IN THE BILE DUCT AND PT REQUIRED SURGICAL INTERVENTION AS A RESULT OF THE PERFORATION. PT DIED DUE TO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS MECHANICAL LITHOTRIPTOR LQC OLYMPUS AMERICA INC. MECH LITHOTRIPOR: BML-4Q-1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death