BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3440498 · Received October 31, 2013

    Report

    Report Number
    2955842-2013-04797
    Event Type
    Malfunction
    Date Received
    October 31, 2013
    Date of Event
    February 22, 2013
    Report Date
    October 1, 2013
    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, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE PATIENT'S POST-SURGICAL COMPLICATIONS AND SUBSEQUENT DEMISE. ISI HAS CONTACTED THE HOSPITAL'S RISK MANAGEMENT DEPARTMENT TO GATHER ADDITIONAL DETAILS REGARDING THE REPORTED EVENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THE DOCUMENTATION PROVIDED DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AND SUBSEQUENTLY EXPIRED FOLLOWING A DA VINCI SI PARTIAL NEPHRECTOMY PROCEDURE.

    Description of Event or Problem · 1

    AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO EXPIRED FOLLOWING A DA VINCI SI PARTIAL NEPHRECTOMY PROCEDURE ON (B)(6) 2013 FOR LEFT LOWER POLE RENAL MASS DISCOVERED WHEN THE PATIENT PRESENTED WITH FLANK PAIN AND HEMATURIA. ISI WAS PROVIDED WITH THE OPERATIVE REPORT FROM THE PRIMARY PROCEDURE. AN ICU ABSTRACT SUMMARY FORM WAS ALSO PROVIDED; HOWEVER, NO RECORD OF THE SECOND SURGERY OR OTHER PROCEDURES WAS PROVIDED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. AFTER THE PATIENT WAS PREPPED THE SURGEON MOBILIZED THE COLON, DISSECTED AND TRANSECTED THE GONADAL, LUMBAR AND ADRENAL VEINS WITH A PK DISSECTOR INSTRUMENT. AN ULTRASOUND WAS USED TO DELINEATE MARGINS, THE HILAR VESSELS CLAMPED, AND THE LOWER POLE REMOVED, THE CUT SURFACE COAGULATED WITH ARGON PLASMA, THE COLLECTING SYSTEM SUTURED CLOSED WITH V-LOCK SUTURE, AND THE KIDNEY EDGES BROUGHT TOGETHER WITH VLOCK SUTURES. FLOSEAL AND SURGICEL WERE PLACED ON THE DEFECT AND CLAMPS REMOVED. THE TOTAL CLAMP TIME WAS 30 MINUTES, AND HEMOSTASIS WAS JUDGED TO BE EXCELLENT. THE SPECIMEN WAS REMOVED AND SURGICAL ENTRY PORTS WERE CLOSED. THERE WERE NO INTRAOPERATIVE COMPLICATIONS. ON (B)(6) 2013, THE PATIENT WAS RETURNED TO THE OR FOR A LAPAROTOMY AND UNDERWENT A NEPHROURETERECTOMY AND REQUIRED TRANSFUSION FOR IATROGENIC HYPOTENSION. THE PATIENT WAS GIVEN A SECONDARY DIAGNOSES OF: ACUTE RESPIRATORY FAILURE SEPTICEMIA NOS SEPSIS ACUTE NECROSIS OF LIVER ACUTE KIDNEY FAILURE, TUBULAR NECROSIS ACUTE POSTHEMORRHAGIC ANEMIA ACCIDENTAL OP LACERATION RECTAL & ANAL HEMORRHAGE COMPLICATIONS PATIENT REQUIRED HEMODIALYSIS ON THE FOLLOWING THREE DAYS AND EXPIRED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561602 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death DAV SI SURG SYS INSTRUMENTS, ACCESSORIES & ESU