BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 376934 · Received February 11, 2002

    Report

    Report Number
    8010047-2002-00003
    Event Type
    Malfunction
    Date Received
    February 11, 2002
    Report Date
    January 10, 2002
    Manufacturer
    THE OLYMPUS OPTICAL CO.
    Product Code
    LQC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A HOSPITAL CHARGE NURSE REPORTED THAT WIRES BROKED INSIDE THE SHEATH OF A DISPOSABLE LITHOCRUSH WHILE THE OPEN BASKET WAS IN THE COMMON BILE DUCT. TO THE BEST OF THE NURSE'S RECOLLECTION, AND ALLEGEDLY SOFT STONE WAS IN THE BASKET AT THE TIME OF THE BREAK. THE PHYSICIAN WIGGLED THE SHEATH TO FREE THE STONE; THE BASKET CLOSED AFTER SEVERAL ATTEMPTS AND THE LITHOCRUSH ASSEMBLY WAS REMOVED FROM THE SCOPE. THE ATTENDING PHYSICIAN PLACED A STENT INTO THE COMMON BILE DUCT AND ENDED THE PROCEDURE. THE PATIENT WAS RESCHEDULED TO RETURN FOR STONE REMOVAL AT A LATER DATE. THERE WERE NO INJURIES ASSOCIATED WITH THE OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS MECHANICAL LITHOTRIPTOR LQC THE OLYMPUS OPTICAL CO. BML-202Q OK3216

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN