BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR V

    MDR report key: 3830425 · Received May 13, 2014

    Report

    Report Number
    8010047-2014-00219
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    LQC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR INVESTIGATION. THE INVESTIGATION CONFIRMED THAT THE PIPE WAS BROKEN AT THE JUNCTION WITH THE WIRE. THERE WERE NO ABNORMALITIES FOUND UPON INVESTIGATION OF THE CONDITION OF THE WELDED PART, THE OUTER DIAMETER AND THE MANUFACTURING RECORD OF THE SAME LOT. THE USER FACILITY REPORTED THAT THE CALCULUS CONTAINED CHOLESTEROL AND IT WAS TOO HARD. THEREFORE, OMSC CONSIDERS THAT THE CONDITION OF PATIENT OR CALCULUS CAUSED THE FAILURE OF CRUSHING CALCULUS. THE DEVICE INSTRUCTION MANUAL HAS WARNED USERS THAT THERE IS POSSIBILITY THE CALCULUS CANNOT BE CRUSHED BY LITHOTRIPTOR, AND IT ALSO DESCRIBES WHAT TO DO IF THE LITHOTRIPTOR CANNOT CRUSH THE CALCULUS. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP (OMSC) WAS INFORMED THAT DURING CRUSHING CALCULUS INSIDE THE BILE DUCT WITH LITHOTRIPTER, THE PIPE BROKE. THE DOCTOR INSERTED A COMPETITOR'S EPBD BALLOON INTO THE ENDOSCOPE ALONG THE BASKET WIRE AND DILATED PAPILLA. THEN, THE BASKET WIRE AND CALCULUS COULD BE REMOVED. THE DOCTOR COMPLETED PROCEDURE AFTER HE PLACED A STENT INTO PANCREAS DUCT FOR PANCREATITIS PREVENTION. THERE WAS NO REPORT OF PATIENT INJURY REGARDING THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285552 OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR V MECHANICAL LITHOTRIPTOR LQC OLYMPUS MEDICAL SYSTEMS CORPORATION BML-V437QR-30 K3X26

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK