BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAKO BIOPSY FORCEPS

    MDR report key: 4372937 · Received December 22, 2014

    Report

    Report Number
    3007591333-2014-00027
    Event Type
    Injury
    Date Received
    December 22, 2014
    Date of Event
    March 10, 2011
    Report Date
    December 22, 2014
    Manufacturer
    ENDOCHOICE INC.
    Product Code
    FCL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A MEDICAL FACILITY THAT THE MAKO BIOPSY FORCEPS CAUSED A LARGER-THAN-EXPECTED TEAR IN A PT'S ESOPHAGUS WITH LOTS OF BLEEDING. NO FURTHER PT INJURIES OR OTHER HEALTH CONSEQUENCES WERE REPORTED. THIS REPORT FOLLOWS A RETROSPECTIVE REVIEW OF COMPLAINTS FOR MEDICAL DEVICE REPORTING REQUIREMENTS BASED ON A NEW PROCEDURE. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION THAT THE MEDICAL DEVICE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843258 MAKO BIOPSY FORCEPS FORCEPS, BIOPSY, NON-ELECTRIC FCL ENDOCHOICE INC. DBC-206 NOT KNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other