BEUDAMED
    FDA Adverse Event Death Summary report: N

    8010047-1998-00038

    MDR report key: 196076 · Received November 2, 1998

    Report

    Report Number
    8010047-1998-00038
    Event Type
    Death
    Date Received
    November 2, 1998
    Date of Event
    October 2, 1998
    Report Date
    October 8, 1998
    Manufacturer
    OLYMPUS OPTICAL CO., LTD
    Product Code
    LQC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING AN ERCP PROCEDURE FOR EXTRACTION OF COMMON BILE DUCT STONES, THE BASKET WIRE BROKE IN THE PT. THE PHYSICIAN WAS ABLE TO REMOVE THE LITHOTRIPTOR BASKET WITH THE STONE FROM THE PT. THE PHYSICIAN THEN ATTACHED A NEW BASKET WIRE TO THE LITHOTRIPTOR HANDLE AND RE-INSERTED IT INTO THE PT. THE PHYSICIAN THEN COMPLETED THE PROCEDURE. THE PT WAS SENT TO THE RECOVERY AREA AND BEGAN PASSING BILE. A PERFORATION OF THE BILE DUCT WAS THEN DETECTED BY THE PHYSICIAN. THE PT WAS RUSHED TO EMERGENCY SURGERY TO REPAIR THE PERFORATION. THE PT WAS REPORTED IN CRITICAL CONDITION FOLLOWING THE SURGERY AND HAS SINCE EXPIRED. THE CUSTOMER REPORTED THAT THE PT WAS ELDERLY AND WAS NOT A GOOD SURGICAL CANDIDATE. THE CAUSE OF DEATH HAS BEEN ATTRIBUTED TO THE PERFORATION OF THE BILE DUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LQC OLYMPUS OPTICAL CO., LTD BML-40 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1