BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR V

    MDR report key: 2251642 · Received August 30, 2011

    Report

    Report Number
    8010047-2011-00196
    Event Type
    Malfunction
    Date Received
    August 30, 2011
    Date of Event
    June 14, 2011
    Report Date
    August 11, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    LQC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS CONTACTED THE USER FACILITY TO OBTAIN ADD'L INFO REGARDING THE REPORT, BUT THE USER FACILITY HAD PROVIDED ONLY LIMITED INFO. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS AMERICA, INC FOR EVAL. THE LITHOTRIPTOR WAS TESTED USING TWO DIFFERENT HANDLES, MODEL MAJ-441, AND MAJ-440. THE BASKET WAS FOUND TO BE OPERATIVE, AND RETRACTED INTO THE SHEATH WITH MINOR RESTRICTION. THE DISTAL BASKET APPEARED IN GOOD ORDER; HOWEVER, THE BASKET WIRES AND INSERTION TUBE WERE OBSERVED TO BE BENT IN MULTIPLE LOCATIONS. THE DEVICE WILL BE FORWARDED TO THE ORIGINAL EQUIPMENT MFR (OEM) FOR FURTHER INVESTIGATION. THE EXACT CAUSE OF THE USER'S EXPERIENCE COULD NOT BE DETERMINED AT THIS TIME, BUT IT APPEARS THE REPORTED DIFFICULTY WAS LIKELY DUE TO USER HANDLING. IF ADD'L AND SIGNIFICANT INFO IS RECEIVED LATER, THIS REPORT WILL BE SUPPLEMENTED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE BASKET WAS ABLE TO CAPTURE THE STONE, BUT COULD NOT BE CLOSED. THE USER DISCONNECTED THE HANDLE, AND THE BASKET REPORTEDLY CAME APART, AND THE USERS THEN PULLED THE ENTIRE SHEATH OFF WITHOUT CUTTING IT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A FLOWER BASKET ((B)(4)) AND A NON-OLYMPUS BALLOON (MODEL UNK). THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR V LITHOCRUSH LQC OLYMPUS MEDICAL SYSTEM CORPORATION BML-V442QR-30 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1