BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 2863240 · Received December 10, 2012

    Report

    Report Number
    2955842-2012-01212
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 6, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, NO MALFUNCTION OF THE DA VINCI SI SYSTEM, INSTRUMENTS OR ACCESSORIES IS ALLEGED TO HAVE OCCUR. A REVIEW OF SYSTEM LOGS FOR THE DATE OF THE EVENT (B)(6) 2012 SHOWED 2 SURGERIES THAT DAY, HOWEVER NEITHER SURGERY HAD A LOGGED ERROR DURING THE PROCEDURE. MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION FROM THE ACCOUNT WERE MADE. TO DATE, NO FURTHER INFORMATION HAS BEEN RECEIVED. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SURGEON PERFORMED TWO DA VINCI SI PROCEDURES, AND BOTH PATIENTS DEVELOPED RHABDOMYOLYSIS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P7

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES