BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3905997 · Received July 1, 2014

    Report

    Report Number
    2955842-2014-03988
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    September 5, 2011
    Report Date
    October 11, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE FOR THE PATIENT'S POST-OPERATIVE COMPLICATION. THERE IS NO REPORT THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2011. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S POST-OPERATIVE COMPLICATIONS. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT UNDERWENT AN X-RAY, WAS FOUND TO HAVE DEVELOPED THROMBOSIS IN HIS LUNG, AND RECEIVED THROMBOLYTIC THERAPY AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S POST-OPERATIVE COMPLICATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI PROSTATECTOMY PROCEDURE, THE TOTAL AMOUNT OF BLEEDING SUSTAINED BY THE PATIENT WAS 300 CC. THE PATIENT REPORTEDLY RECEIVED A TRANSFUSION WITH A TOTAL OF 800 CC. DURING THE SURGICAL PROCEDURE, NO MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY WAS REPORTED OR OBSERVED. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE NEXT MORNING, THE PATIENT BECAME BROOD-PRESSURE [SIC] REDUCTIONS AND INDUCED TACHYSYSTOLE. AN X-RAY REVEALED THAT THE LEFT LOWER LOBE OF THE PATIENT'S LUNG HAD BECOME THROMBOSED. THE PATIENT UNDERWENT THROMBOLYTIC THERAPY AND WAS REPORTEDLY GETTING WELL. THE INITIAL REPORTER INDICATED THAT THE SURGEON BELIEVED THAT A POSSIBLE CAUSE OF THE THROMBOSIS WAS DUE TO THE PROLONGED SURGERY TOTALING APPROXIMATELY 7.5 HOURS. HOWEVER, THE SURGEON DID NOT KNOW THE ACTUAL CAUSE OF THE THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382368 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention