BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3348109 · Received September 13, 2013

    Report

    Report Number
    2955842-2013-03555
    Event Type
    Injury
    Date Received
    September 13, 2013
    Date of Event
    August 22, 2012
    Report Date
    August 16, 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 OPERATIVE REPORTS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. ISI HAS ATTEMPTED TO CONTACT THE SITE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP; HOWEVER, AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE OF (B)(4) 2012, FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. 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 SI SURGICAL HYSTERECTOMY PROCEDURE.

    Description of Event or Problem · 1

    AS PART OF A LEGAL MEDIATION EFFORT, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION AND MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGO OOPHORECTOMY PROCEDURE ON (B)(6) 2012, FOR CHRONIC PELVIC AND ABDOMINAL PAIN AND ENDOMETRIOSIS. THE PATIENT STARTED TO HAVE PELVIC AND ABDOMINAL PAIN WHEN SHE WAS DIAGNOSED WITH ENDOMETRIOSIS 10 YEARS PRIOR TO THE DA VINCI SURGICAL PROCEDURE. HER PELVIC PAIN AND ABDOMINAL PAIN STARTED TO WORSEN 3 WEEKS PRIOR TO THE DA VINCI PROCEDURE. THE PATIENT HAD CONSTANT LOWER ABDOMINAL PAIN, LOW BACK PAIN, IRREGULAR MENSES AND BLEEDING BETWEEN HER PERIODS AS WELL. SHE ALSO HAD BLOOD STOOLS FOR THE 6 MONTHS PRIOR TO THE DA VINCI SURGICAL PROCEDURE. THE MEDICAL RECORD NOTED THAT THE RISKS, BENEFITS, AND ALTERNATIVES TO THE DA VINCI SURGICAL PROCEDURE WERE DISCUSSED WITH THE PATIENT. THE RISKS DISCUSSED INCLUDED BUT WERE NOT LIMITED TO BLEEDING, INFECTION, GASTROINTESTINAL/GENITOURINARY INJURY, RISK OF INJURY, RISK OF DEEP VEIN THROMBOSIS, AND THE RARE COMPLICATION OF DEATH. THE PATIENT UNDERSTOOD AND WISHED TO PROCEED WITH THE PROCEDURE. PER THE OPERATIVE REPORT FOR THE (B)(6) 2012 DA VINCI SURGICAL PROCEDURE, THE SURGEON NOTED SEVERAL AREAS WITH ADHESIONS, ENDOMETRIAL IMPLANTS, AND A HEMORRHAGIC CYST ON THE OVARY. THE SURGEON LYSED THE ADHESIONS, EXCISED THE ENDOMETRIOSIS, AND COMPLETED THE HYSTERECTOMY PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE WELL AND NO COMPLICATIONS WERE NOTED. THE PATIENT'S IMMEDIATE POSTOPERATIVE CONDITION WAS EXCELLENT. THE OPERATIVE REPORTS DID NOT CONTAIN ANY REPORT OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT SOUGHT AND RECEIVED MEDICAL ATTENTION FOR ABDOMINAL PAIN, CONSTIPATION, VAGINAL BLEEDING, PELVIC PAIN, VAGINAL TEARS, AND VAGINAL CUFF DEHISCENCE REPAIR FROM (B)(6) 2012 TO (B)(6) 2013. ON (B)(6) 2012, THE PATIENT VISITED THE DOCTOR'S OFFICE DUE TO VAGINAL BLEEDING WHICH STARTED AFTER HAVING INTERCOURSE. THE BLEEDING WAS CONTROLLED BY THE TIME SHE VISITED THE DOCTOR AND SHE WAS ADVISED TO COME BACK TO THE EMERGENCY ROOM (ER) IF THE SYMPTOMS WORSENED. IN (B)(6) 2012, THE PATIENT EXPERIENCED POST-OPERATIVE VAGINAL BLEEDING, WHICH WAS TREATED BY CAUTERIZATION. ON (B)(6) 2012, SHE PRESENTED TO THE ER WITH INCREASED PAIN AND VAGINAL BLEEDING. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND A REPAIR OF VAGINAL CUFF DEHISCENCE WAS PERFORMED. HER PAIN AND VAGINAL BLEEDING WERE WELL CONTROLLED AFTER THE OPERATION SO SHE WAS DISCHARGED HOME ON THE SAME DAY. THE PATIENT'S CURRENT CONDITION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461610 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000, A60.P8

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES