BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAKO BIOPSY FORCEPS

    MDR report key: 4372924 · Received December 22, 2014

    Report

    Report Number
    3007591333-2014-00025
    Event Type
    Injury
    Date Received
    December 22, 2014
    Date of Event
    May 12, 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
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A MEDICAL FACILITY THAT THE MAKO BIOPSY FORCEPS WERE CAUSING TISSUE TEARING. NO FURTHER PT INJURIES OR OTHER HEALTH CONSEQUENCES WERE REPORTED. THIS REPORT FOLLOWS A RETROSPECTIVE WERE REPORTED. THIS REPORT FOLLOWS A RETROSPECTIVE REVIEW OF COMPLAINTS FOR MEDICAL DEVICE REPORTING REQUIREMENTS BASED ON A NEW PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843253 MAKO BIOPSY FORCEPS FORCEPS, BIOPSY, NON-ELECTRIC FCL ENDOCHOICE INC. DBC-206 NOT KNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other