BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI ROBOT

    MDR report key: 4093177 · Received September 9, 2014

    Report

    Report Number
    MW5038187
    Event Type
    Injury
    Date Received
    September 9, 2014
    Date of Event
    November 10, 2010
    Report Date
    September 9, 2014
    Manufacturer
    INTUITIVE SURGICAL
    Product Code
    NAY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I UNDERWENT ROBOTIC PROSTATE SURGERY AT (B)(6) WITH (B)(6) (NOW AT (B)(6)) ON (B)(6) 2010. OPERATING NOTES SHOWED PERFECT RESULTS. I LATER DISCOVERED USING OUTSIDE UROLOGIST, THAT MY URINARY SPHINCTER HAD BEEN CUT FROM 2 TO 8 O'CLOCK, AND WAS AN OBVIOUS DEFECT WITHOUT ANY HOPE OF RECOVERY. I SUPPLIED (B)(6) WITH THE FINDINGS AND THE UROLOGIST REPORT, WHICH HE RUDELY DISREGARDS AND FAILED TO ACKNOWLEDGE ANY RESPONSIBILITY OR ACCOUNTABILITY. I ASKED HOW THIS OP NOTES SHOWED NO TRACE OF ANY ISSUES, TO WHICH HE MADE DEFLECTIVE STATEMENTS. HIS ACTIONS REFLECT THAT OF GUILT AND COVERING UP ADVERSE EVENTS. I APPROACHED THE HOSP WITH THE SAME RESULTS AS THEY POINTED OUT THAT THE OPERATING NOTES SHOWED NO ISSUES. I AM PROOF THAT THERE WERE ADVERSE RESULTS, BEING DESCRIBED AS UNIVERSALLY INCONTINENT AND IMPOTENT DUE TO ROBOTIC SURGERY. (B)(6) HAS CHOSEN TO COVER UP THE NEGATIVE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556325 DA VINCI ROBOT DAVINCI NAY INTUITIVE SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other