BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3441347 · Received October 31, 2013

    Report

    Report Number
    2955842-2013-04850
    Event Type
    Injury
    Date Received
    October 31, 2013
    Date of Event
    October 19, 2010
    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 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 TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE ON (B)(6) 2010 FOR UNSPECIFIED REASONS. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND A SURGICAL PATHOLOGY REPORT. PROGRESS NOTES FROM (B)(6) 2011 NOTE THE EXISTENCE OF A RECTANGULAR AREA OF 30 X 40CM IN THE SHAPE OF A HEATING PAD THAT MIGHT BE A BURN FROM EXCESSIVE HEATING PAD USE. THIS WAS CIRCLED WITH AN ASTERISK. HER VAGINAL CUFF WAS NOTED TO BE NOT YET COMPLETELY HEALED, BUT LOOKED GOOD. 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. THE PROCEDURE ITSELF WAS UNREMARKABLE AND GOOD HEMOSTASIS WAS ACHIEVED. ADHESIONS OF THE SIGMOID COLON TO THE LEFT PELVIC SIDEWALL WERE NOTED. SURGICEL WAS PLACED OVER THE VAGINAL CUFF TO ENSURE HEMOSTASIS. THE URETERS WERE INSPECTED AND NOTED TO BE PERISTALSING NICELY AND LATERAL TO THE UTERINE PEDICLES BILATERALLY. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2011, AN OPERATIVE NOTE STATED THAT THE PATIENT PRESENTED WITH PAIN OF 'ONE YEAR DURATION' WHICH WOULD BE FROM (B)(6) 2010. THE HYSTERECTOMY WAS PERFORMED IN (B)(6) 2010. AN EXPLORATORY LAPAROSCOPIC EXAM DIAGNOSED THE PATIENT WITH ENDOMETRIOSIS IN (B)(6) 2010. PATIENT REPORTED ENDOMETRIOSIS ON LEFT OVARY AND SIDEWALL. SINCE THE SURGERY, SHE HAS HAD URINARY RETENTION, NAUSEA, VOMITING, CONSTIPATION AND FECAL INCONTINENCE. CT AND ULTRASOUND EXAMS NOTED A DILATED APPENDIX AND AN OVARIAN CYST. THE PATIENT DESIRED A LAPAROSCOPIC OOPHORECTOMY. A SPECULUM EXAM NOTED GRANULATION TISSUE AT THE APEX OF THE VAGINA, WHICH WAS DETERMINED TO BE HEALED TISSUE FROM HER HYSTERECTOMY. THE PROCEDURE WAS DONE NON-ROBOTICALLY. A BIOPSY WAS TAKEN AND SILVER NITRATE APPLIED. FILMY ADHESIONS WERE NOTED ONCE THE LAPAROSCOPE WAS PLACED. THE APPENDIX LOOKED UNREMARKABLE. THE LEFT OVARY WAS RETRACTED FROM THE SIDEWALL AND THE URETER WAS MOBILIZED AWAY, NOTED TO BE FREELY PERISTALSING. THE ABDOMEN EXHIBITED NO SCAR TISSUE. THE APPENDIX WAS REMOVED AND FILMY ADHESIONS LYSED LOW IN THE PELVIS. THE CUFF WAS INSPECTED AND LOOKED HEALED. BOWEL EXHIBITED NO GROSS ABNORMALITIES. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS RETURNED TO THE RECOVERY ROOM IN STABLE CONDITION. SHE WAS DISCHARGED ON (B)(6) 2011. ON (B)(6) 2012, THE PATIENT PRESENTED WITH NAUSEA AND VOMITING, FEVER AND THE CHILLS. SHE STATED SHE HAS PAIN SYNDROME SECONDARY TO PELVIC NERVE DAMAGE AFTER MULTIPLE LAPAROSCOPIC PROCEDURES. X-RAY DEMONSTRATED A NEW SMALL RIGHT BASILAR OPACITY CONSISTENT WITH PNEUMONIA. A CT SCAN SHOWED MILD INFILTRATION IN THE MESENTERY, WITH SEVERAL NODES PROMINENT. DIFFUSE FATTY LIVER INFILTRATION. A 1.4 CM RENAL LEFT LESION WAS NOTED, SIMILAR IN SIZE TO THAT OF (B)(6) 2010. NO ADDITIONAL INFORMATION IS AVAILABLE AFTER THIS REPORT OF (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559685 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000, A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES