BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTUITIVE SURGICAL INC. - DAVINCI ROBOT SI

    MDR report key: 6759980 · Received July 31, 2017

    Report

    Report Number
    MW5071325
    Event Type
    Injury
    Date Received
    July 31, 2017
    Date of Event
    July 27, 2017
    Report Date
    July 31, 2017
    Manufacturer
    INTUITIVE SURGICAL
    Product Code
    NAY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING ROBOTIC HYSTERECTOMY, DAVINCI FENESTRATED BIPOLAR TIP BROKE OFF INSIDE THE PT AS THE DOCTOR WAS CLOSING THE VAGINAL CUFF. TWO PIECES WERE RETRIEVED BUT A THIRD PIECE WAS NOT FOUND. FLUORO IMAGES WERE NEGATIVE. NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535536 INTUITIVE SURGICAL INC. - DAVINCI ROBOT SI DAVINCI ROBOT SI NAY INTUITIVE SURGICAL SH0265 N10170508

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention