BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS MECHANICAL LITHOTRIPTOR

    MDR report key: 1841076 · Received September 16, 2010

    Report

    Report Number
    8010047-2010-00175
    Event Type
    Injury
    Date Received
    September 16, 2010
    Date of Event
    November 6, 2009
    Report Date
    August 18, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    LQC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS MADE SEVERAL ATTEMPTS TO OBTAIN ADD'L INFO REGARDING THE REPORT FROM THE PHYSICIAN SAID TO HAVE PERFORMED THE PROCEDURE, BUT DID NOT RECEIVE ADD'L INFO REGARDING THE REPORTED EVENT. THE SPECIFIC MODEL, LOT NUMBER OF THE MECHANICAL LITHOTRIPTOR ALLEGEDLY INVOLVED IN THE REPORTED EVENT REMAINS UNK. NO DEVICES INVOLVED IN THIS REPORT HAS BEEN RETURNED TO OLYMPUS FOR EVAL. THE EXACT CAUSE OF THE PT'S OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED. IF ADD'L AND SIGNIFICANT INFO BECOMES AVAILABLE LATER THIS REPORT WILL BE UPDATED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE. CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WITH A SPHINCTEROTOMY, THE USER UTILIZED AN OLYMPUS MECHANICAL LITHOTRIPTOR TO CRUSH A BILE DUCT STONE. THE USER WAS ABLE TO CAPTURE THE STONE IN THE BASKET, BUT WHILE ADVANCING THE METAL SHEATH, IT WAS REPORTED THAT THE USER DISCOVERED THAT THE METAL HANDLE OF THE MECHANICAL LITHOTRIPTOR WAS MALFUNCTIONING (THE METAL WHEEL OF THE HANDLE WOULD ONLY CLICK BUT NOT TIGHTEN); THE USER REMOVED THE LITHOTRIPTOR HANDLE, CUT THE PIPE AND REMOVED BOTH THE MECHANICAL LITHOTRIPTOR AND THE SCOPE FROM THE WIRE. THE USER UTILIZED A NON-OLYMPUS MECHANICAL LITHOTRIPTOR (SOEHENDRA LITHOTRIPTOR) AND FED THE WIRES THROUGH THE CABLE AND THEN ATTACHED THE SOEHENDRA CRANK. IT WAS REPORTED THAT THE USER HAD ATTACHED THE WIRES TO THE FAR END OF THE HANDLE SO THAT WHEN HE TURNED THE HANDLE OF THE SOEHENDRA DEVICE, IT BROKE THE WIRES AT THE LEVEL OF THE ROTATING BAR. THE PT WAS REPORTEDLY LEFT WITH WIRES EXTENDING FROM HIS MOUTH FOR SEVERAL DAYS AND WAS TRANSFERRED TO A SECOND UNIDENTIFIED FACILITY FOR FURTHER INTERVENTION. THE PT ALLEGEDLY SUSTAINED PERMANENT INJURY TO HIS MOUTH AND THROAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS MECHANICAL LITHOTRIPTOR LITHOTRIPTOR LQC OLYMPUS MEDICAL SYSTEMS CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 SOEHENDRA LITHOTRIPTOR| BASKET WIRES MODEL UNK