BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAKO BIOPSY FORCEPS

    MDR report key: 6121778 · Received November 22, 2016

    Report

    Report Number
    3007591333-2016-00061
    Event Type
    Injury
    Date Received
    November 22, 2016
    Date of Event
    October 25, 2016
    Report Date
    November 17, 2016
    Manufacturer
    ENDOCHOICE, INC.
    Product Code
    FCL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE FORCEPS, THE USER NEEDED TO PULL THE TISSUE WITH THE FORCEPS RESULTING IN TEARING OF THE TISSUE WITH BLEEDING. THE USER STATED THAT CUTTING WITH THE GRASPER JAWS WAS NOT UNIFORM. NO FURTHER PATIENT INJURY OR OTHER HEALTH CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772474 MAKO BIOPSY FORCEPS FORCEPS, BIOPSY, NON-ELECTRIC FCL ENDOCHOICE, INC. DBC-207 BF160411

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization