BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3443794 · Received November 1, 2013

    Report

    Report Number
    2955842-2013-04898
    Event Type
    Injury
    Date Received
    November 1, 2013
    Date of Event
    April 18, 2012
    Report Date
    October 4, 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 POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THE MEDICAL RECORDS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATED TO THIS EVENT. 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: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI ANTERIOR EXENTERATION, INCLUDING CYSTECTOMY, HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2012 FOR CHRONIC PYOCYSTIS AND NEUROGENIC BLADDER. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. AN OPEN HASSON TECHNIQUE WAS USED TO ENTER THE PERITONEAL CAVITY. EXTENSIVE ADHESIONS WERE SEEN UPON INSERTION OF THE LAPAROSCOPE. THESE WERE MOSTLY IN THE MIDLINE AND ADJACENT TO THE ILEAL CONDUIT IN THE RIGHT LOWER QUADRANT. THEY WERE TAKEN DOWN USING COLD SHEARS PRIOR TO DOCKING THE DA VINCI SYSTEM. THE BLADDER, UTERUS AND OVARIES WERE COMPLETELY DISSECTED AND DELIVERED THROUGH THE VAGINAL APEX. HEMOSTASIS IN THE PELVIS WAS CONFIRMED. THE ILEAL CONDUIT WAS CAREFULLY INSPECTED AND IRRIGATED TO CONFIRM NO INJURY. CAREFUL INSPECTION OF THE BOWEL UNDERNEATH THE PRIOR ADHESIONS NOTED NO INJURY. AN ON-Q PAIN PUMP WAS PUT INTO PLACE SUBCUTANEOUSLY. ESTIMATED BLOOD LOSS WAS 900 ML. THE PATIENT WAS ALLOWED TO WAKE UP, WAS EXTUBATED AND TAKEN TO THE RECOVERY ROOM HAVING TOLERATED THE PROCEDURE WELL. SHE WAS DISCHARGED ON (B)(6) 2012 FOR TOTAL STAY OF FIVE DAYS. ON (B)(6) 2012, THE PATIENT PRESENTED TO THE ER WITH ABDOMINAL DISTENSION, VOMITING AND NAUSEA. SHE WAS ADMITTED TO THE ICU. A CT SCAN REVEALED A PERFORATED VISCUS AND INTRAPERITONEAL AIR. A LAPAROSCOPIC EXAM WAS CARRIED OUT WITH PERITONEAL WASHOUT. THEN AN EXPLORATORY LAPAROTOMY WAS PERFORMED FOR REPAIR OF THE PERFORATED VISCUS. FECAL PERITONITIS WAS DISCOVERED AND THE PERFORATED SMALL BOWEL WAS CLOSED AND FOUND TO BE WATERTIGHT. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS STABLE AT THE END OF THE PROCEDURE. SHE RETURNED TO THE HOSPITAL ON (B)(6) 2012 WITH AN ABDOMINAL WALL WOUND. A PICC LINE WAS PLACED IN THE RIGHT UPPER EXTREMITY. DEEP VEIN THROMBOSIS WAS DIAGNOSED. SHE WAS DISCHARGED ON (B)(6) 2012. NO ADDITIONAL INFORMATION IS AVAILABLE AFTER HER DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563099 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000, A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| R DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES