BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAKO BIOPSY FORCEPS

    MDR report key: 5823497 · Received July 26, 2016

    Report

    Report Number
    3007591333-2016-00040
    Event Type
    Injury
    Date Received
    July 26, 2016
    Date of Event
    July 6, 2016
    Report Date
    July 13, 2016
    Manufacturer
    ENDOCHOICE, INC.
    Product Code
    FCL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN TAKING A BIOPSY OF A SMALL POLYP, MORE BLEEDING THAN NORMAL WAS NOTICED. TO STOP THE BLEEDING THE SITE HAD TO BE CLIPPED AND CAUTERIZED. THERE WAS NO FURTHER PATIENT INJURY OR OTHER ADVERSE HEALTH CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474620 MAKO BIOPSY FORCEPS FORCEPS, BIOPSY, NON-ELECTRIC FCL ENDOCHOICE, INC. DBC-206 BF160331

    Patients

    Seq Age Sex Outcome Treatment
    1 115 YR Required Intervention