BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE BIOPSY FORCEPS

    MDR report key: 4212793 · Received October 24, 2014

    Report

    Report Number
    2951238-2014-00455
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 7, 2014
    Manufacturer
    OLYMPUS MED SYS CORP
    Product Code
    FCL
    PMA / PMN Number
    K955065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION, AS IT HAS BEEN DISCARDED FOLLOWING THE PROCEDURE. THEREFORE, THE EXACT CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME, HOWEVER, THE USER'S TECHNIQUE IN USING THE DEVICE COULD NOT BE RULED OUT AS A CONTRIBUTORY FACTOR TO THE REPORTED EVENT. IF ADDITIONAL INFO BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A DIAGNOSTIC COLONOSCOPY PROCEDURE, IT WAS STATED THAT THE TISSUE WAS RIPPED, WHILE TAKING A TISSUE BIOPSY. THERE WAS MODERATE TO SEVERE BLEEDING OBSERVED. THE BLEEDING WAS CONTROLLED USING ADDITIONAL CLIPS. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER SIMILAR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678915 DISPOSABLE BIOPSY FORCEPS BIOPSY FORCEPS FCL OLYMPUS MED SYS CORP FB-220U NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other