BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR V

    MDR report key: 2843755 · Received October 25, 2012

    Report

    Report Number
    8010047-2012-00407
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    September 27, 2012
    Report Date
    September 27, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FEO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED-UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFO REGARDING THIS REPORT. THE USER FACILITY REPORTED THAT THE PT WAS AN IN-PATIENT AND A GALL BLADDER SURGERY HAD BEEN SCHEDULED TO BE PERFORMED THE FOLLOWING DAY. THE USER FACILITY REPORTED THAT THE PT'S COMMON BILE DUCT WAS FILLED WITH STONES, AND 1/3 OF THE STONES WERE REMOVED WHILE THE REMAINDER STONES WERE "STACK ON TOP OF ONE ANOTHER". THE USER FACILITY REPORTED THAT THE PT WAS VISITED ON (B)(6) 2012 AND WAS FOUND DOING WELL. THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVAL. THE EXACT CAUSE OF THE USER'S EXPERIENCE COULD NOT BE CONCLUSIVELY DETERMINE. HOWEVER, THE SIZE, HARDNESS AND EXCESSIVE QUANTITY OF STONES COULD NOT BE RULED OUT AS A CONTRIBUTORY FACTOR. 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 A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE REFERENCED DEVICE WAS WORKING FINE BUT POSSIBLY ENCOUNTERED A LARGE AND HARD STONE WHICH CAUSED THE SHEATH, WIRE BASKET, AND THE ENDOSCOPE TO BE STUCK INSIDE THE PT. THE USERS EVENTUALLY MANAGED TO CUT AND REMOVE THE SHEATH AND THE ENDOSCOPE WITH THE BASKET REMAINING. THE PT REPORTEDLY HAD TO UNDERGO AN OPEN SURGERY FOR BASKET REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR V MECHANICAL LITHOTRIPTOR FEO OLYMPUS MEDICAL SYSTEMS CORPORATION BML-V442QR-26 1ZK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention OLYMPUS TJF-180V ENDOSCOPE WITH UNK SERIAL NUMBER