BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 2001786 · Received February 9, 2011

    Report

    Report Number
    2955842-2011-00042
    Event Type
    Other
    Date Received
    February 9, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 10, 2011
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    PMA / PMN Number
    K081207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ALLEGATIONS OF DEFICIENCY WITH THE DA VINCI S SURGICAL SYSTEM WERE REPORTED. BASED ON THE INFO RECEIVED, IT WAS DETERMINED THAT THE DA VINCI S SURGICAL SYSTEM WORKED AS INTENDED AND NO SYSTEM MALFUNCTIONS OCCURRED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, INTUITIVE SURGICAL RECEIVED A LEGAL SUMMONS AND COMPLAINT FILED BY A PT ALLEGING THAT THEY SUFFERED SIGNIFICANT INJURY AND DAMAGES DUE TO THE SURGEON'S INABILITY TO PROVIDE REASONABLY PRUDENT MEDICAL CARE AFTER A DA VINCI S EXCISION OF ENDOMETRIOSIS INCLUDING A PARTIAL THICKNESS SIGMOID COLON RESECTION PROCEDURE WAS PERFORMED. THE SURGERY TOOK APPROX 10 HOURS TO COMPLETE AND POST OPERATIVELY, THE PT HAD CT FINDINGS CONSISTENT WITH A PERFORATED VISCUS AND DEVELOPING ABSCESS. THE COMPLAINT FURTHER ALLEGES THAT THE PT HAS UNDERGONE NUMEROUS MEDICAL PROCEDURES (INCLUDING ADD'L SURGERIES) DUE TO THE SURGEON'S FAILURE TO PROPERLY, ADEQUATELY OR TIMELY MONITOR, MANAGE, DIAGNOSE, REFER, CONSULT, INFORM AND TREAT THE PT'S MEDICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM, NAY NAY INTUITIVE SURGICAL, INC. IS2000 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R ACCESSORIES| DA VINCI S SYSTEM INSTRUMENTS &