BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BML-4Q

    MDR report key: 101045 · Received June 25, 1997

    Report

    Report Number
    2429304-1997-00020
    Event Type
    Malfunction
    Date Received
    June 25, 1997
    Date of Event
    May 23, 1997
    Report Date
    June 10, 1997
    Manufacturer
    OLYMPUS OPTICAL CO. LTD./SHINJUKU SAN-EI BLDG
    Product Code
    FFK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MECHANICAL LITHOTRIPTER BECAME LODGED IN THE COMMON BILE DUCT OF THE PT BECAUSE THE STONE RETRIEVAL BASKET COULD NOT BE CLOSED DURING LITHOTRIPSY. THE BASKET WAS REMOVED DURING SUBSEQUENT SURGERY AND THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BML-4Q BML-4Q MECHANICAL LITHOTRIPTOR (SLIDE TYPE) FFK OLYMPUS OPTICAL CO. LTD./SHINJUKU SAN-EI BLDG MD-564 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR