BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 1012698 · Received March 15, 2008

    Report

    Report Number
    8010047-2008-00041
    Event Type
    Malfunction
    Date Received
    March 15, 2008
    Date of Event
    February 13, 2008
    Report Date
    February 14, 2008
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    LQC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE OLYMPUS LITHOTRIPTOR UTILIZED IN THE PROCEDURE WAS RETURNED TO OLYMPUS FOR INVESTIGATION. THE INVESTIGATION CONFIRMED THE USER'S REPORT OF THE DAMAGED LITHOTRIPTOR. ONE OF THE FOUR BASKET WIRES WAS OBSERVED TO BE FRACTURED, BUT REMAINED ATTACHED TO THE DISTAL TIP OF THE BASKET. THE CAUSE OF THE USER'S EXPERIENCE WAS DETERMINED TO BE DUE TO THE BILIARY STONE BEING EXCESSIVELY HARD AND LARGE. THIS REPORT IS BEING FILED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT A PT HAD BEEN TRANSPORTED TO THEIR FACILITY WITH ANOTHER CO'S BASKET WIRE LITHOTRIPTOR LODGED AROUND A VERY HARD BILIARY STONE. THE USER FACILITY PERFORMED A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) TO REMOVE THE STONE AND FREE THE WIRE BASKET. THE NON-OLYMPUS LITHOTRIPTOR DEVICE WAS SUCCESSFULLY REMOVED, AND THE USERS THEN ATTEMPTED TO REMOVE THE STONE USING AN OLYMPUS DEVICE, HOWEVER, THE USERS REPORTED THAT THE STONE WAS REPORTEDLY TOO "CONCRETE" AND A THREAD OF ONE OF THE FOUR BASKET WIRES UNRAVELLED BUT REMAINED ATTACHED TO THE DISTAL TIP OF THE BASKET. THE LITHOTRIPTOR WAS REMOVED FROM THE PT AND ANOTHER DEVICE LITHOTRIPTOR WAS UTILIZED. UPON THIS ATTEMPT, A LOOSE STRAND OF ONE OF THE BASKET WIRES INSIDE THE SHEATH REPORTEDLY FRACTURED, BUT THE USERS WERE ABLE TO CRUSH THE STONE, REMOVE THE LITHOTRIPTOR, AND COMPLETE THE PROCEDURE. THE USER FACILITY REPORTED THAT NO PORTIONS OF THE DEVICES FELL INSIDE THE PT AND THERE WAS NO PT INJURY. IN ADDITION, THE USER FACILITY STATED THAT THE CAUSE OF THIS PHENOMENON WAS DUE TO THE NATURE OF THE BILIARY STONE BEING SO HARD AND LARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR V LQC OLYMPUS MEDICAL SYSTEMS CORPORATION BML-V442QF 74K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK