BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3885070 · Received June 19, 2014

    Report

    Report Number
    2955842-2014-03792
    Event Type
    Other
    Date Received
    June 19, 2014
    Date of Event
    May 10, 2014
    Report Date
    May 22, 2014
    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, ISI HAS NOT DETERMINED THE ROOT CAUSE OF THE INTRA-OPERATIVE BLEEDING EXPERIENCED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI GASTRECTOMY PROCEDURE, THE PATIENT BLED FROM A BRANCH OF VESSELS LOCATED NEAR THE STOMACH'S DUODENUM VEIN, REQUIRING THE PATIENT TO UNDERGO A BLOOD TRANSFUSION. BASED ON THE INFORMATION PROVIDED, THERE WAS NO REPORT THAT THE INTRA-OPERATIVE BLEEDING EXPERIENCED BY THE PATIENT WAS DUE TO A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES. IN ADDITION, THERE WAS NO REPORT THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES OCCURRED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI GASTRECTOMY PROCEDURE, IT WAS OBSERVED THAT THE PATIENT WAS BLEEDING FROM A BRANCH OF VESSELS NEAR THE STOMACH'S DUODENUM VEIN. DUE TO THE BLEEDING EXPERIENCED BY THE PATIENT, THE SURGEON MADE THE DECISION TO COMPLETE THE PLANNED PROCEDURE USING OPEN SURGICAL TECHNIQUES. THERE WAS NO REPORT THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. RECEIVED ADDITIONAL INFORMATION FROM THE INITIAL REPORTER. THE INITIAL REPORTER INDICATED THAT THE PATIENT HAD STOMACH CANCER. THERE WAS NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES DURING THE SURGICAL PROCEDURE THAT CAUSED THE BLEEDING EXPERIENCED BY THE PATIENT. THE INITIAL REPORTER INDICATED THAT IT IS UNKNOWN WHAT CAUSED THE BLEEDING EXPERIENCED BY THE PATIENT AND THE SURGEON DID NOT INDICATE THAT THE BLEEDING EXPERIENCED BY THE PATIENT WAS ASSOCIATED WITH AN INJURY OR BLEEDING THAT OCCURRED AS A RESULT OF UNDERGOING A SURGICAL PROCEDURE. THE BRANCH OF VESSELS THAT THE PATIENT BLED FROM WAS NOT PROVIDED. THE OPEN SURGICAL PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS AND THE PATIENT DID NOT EXPERIENCE ANY POST-SURGICAL COMPLICATIONS. THE INITIAL REPORTER INDICATED THAT THE PATIENT LOST APPROXIMATELY 2000 CC OF BLOOD AND REQUIRED A BLOOD TRANSFUSION. THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361308 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other