BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE MECHANICAL LITHOTRIPTOR V

    MDR report key: 3190809 · Received June 14, 2013

    Report

    Report Number
    8010047-2013-00154
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 17, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OMSC FOLLOWED UP WITH THE FACILITY TO OBTAIN MORE DETAILED INFORMATION. IT WAS REPORTED THAT THE STONE OF THE PT WAS CRUSHED SUCCESSFULLY BY AN ESWL AT THE OTHER FACILITY, AND THE BASKET WIRE WAS RETRIEVED FROM THE PT. TWO DAYS AFTER THE ESWL, THE STONE WAS REPORTEDLY RETRIEVED UNDER ENDOSCOPY. THE PT REPORTEDLY WAS DOING FINE AFTER THE PROCEDURE. THE USER FACILITY ALSO REPORTED THAT THE STONE WAS MORE THAN 20 MM IN SIZE. ONLY THE BASKET WIRE OF THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE BASKET DEFORMED SEVERELY AND THE BASKET WIRE BROKE NEAR THE PROXIMAL END. THERE WERE NO OTHER ABNORMALITIES RELATED TO THE BREAKAGE IN THE SUBJECT DEVICE AND IN THE MANUFACTURING RECORD OF THE SUBJECT PRODUCT. BASED ON THE PREVIOUS INVESTIGATION THE CAUSE OF THE USER'S EXPERIENCE WAS DETERMINED TO BE DUE TO THE BILIARY STONE BEING EXCESSIVELY HARD. 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 AN ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY (ERCP) FOR A BILIARY STONE LITHOTRIPSY, THE DEVICE WAS SUCCESSFULLY PLACED OVER THE STONE, HOWEVER, THE DEVICE COULD NOT CRUSH THE STONE AND COULD NOT BE WITHDRAWN FROM THE PT. THE USER FACILITY REPORTEDLY TRIED TO CRUSH THE STONE WITH A MECHANICAL LITHOTRIPTOR ((B)(4)), HOWEVER THE STONE COULD NOT BE CRUSHED BECAUSE THE BASKET WIRE GOT SNAPPED AND SHORTEN AT THE PROXIMAL END AND COULD NOT BE RETRIEVED FROM THE PT. IT WAS REPORTED THAT THE PROCEDURE WAS ABANDONED AND THE PT WAS TRANSFERRED TO THE OTHER FACILITY FOR ESWL CONSIDERING THE ADVANCED AGE OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272259 SINGLE USE MECHANICAL LITHOTRIPTOR V MECHANICAL LITHOTRIPTOR FEO OLYMPUS MEDICAL SYSTEMS CORPORATION BML-V237QR-30 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR