BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 1073704 · Received July 1, 2008

    Report

    Report Number
    8010047-2008-00109
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 1, 2008
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR INVESTIGATION. REGULATORY AFFAIRS COULD NOT CONCLUSIVELY DETERMINE THE USER'S REPORT DUE TO THE LACK OF DEVICE TO INVESTIGATE. THE CAUSE OF THE USER'S EXPERIENCE COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF THE DEVICE IS RECEIVED AT A LATER DATE AND FURTHER INFORMATION IS OBTAINED, THIS REPORT WILL BE REOPENED.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT THE HOT BIOPSY FORCEPS FAILED ON AN UNSPECIFIED NUMBER OF OCCASIONS AND WOULD NOT COAGULATE, EVEN WHEN THE CURRENT WAS INCREASED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT HOT BIOPSY ELECTRODE WITH NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS HOT BIOPSY FORCEPS KNW OLYMPUS MEDICAL SYSTEMS CORPORATION FD-7C-1.B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other