BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3359523 · Received September 20, 2013

    Report

    Report Number
    2955842-2013-03708
    Event Type
    Injury
    Date Received
    September 20, 2013
    Date of Event
    March 14, 2012
    Report Date
    August 21, 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. 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 SYSTEM, INSTRUMENT OR ACCESSORY. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS FOLLOWING A DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY.

    Description of Event or Problem · 1

    AS PART OF A LEGAL MEDIATION EFFORT ON AUGUST 21, 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2012 WITH A PRE-OPERATIVE DIAGNOSIS OF MENORRHAGIA, PELVIC PAIN AND THE DESIRED DEFINITIVE THERAPY. THE PATIENT'S MEDICAL RECORDS STATE THAT THE RISKS, BENEFITS AND ALTERNATIVES TO ROBOTIC SURGERY AND HYSTERECTOMY WERE DISCUSSED WITH THE PATIENT, AND THE PATIENT UNDERSTOOD AND CONSENTED. ACCORDING TO THE PATIENT'S OPERATIVE (OP) REPORT, A 10MM INCISION AT THE UMBILICUS WAS CREATED, AND A CAMERA PORT WAS INSERTED UNDER DIRECT VISION WITH A 10MM LAPAROSCOPE. UPON ENTRY, THE OP REPORT STATES THERE APPEARED TO BE SOME OMENTAL GRAZING, WITH NO EVIDENCE OF ANY INJURIES. UPON REPEAT INSPECTION OF THE BOWEL, NO EVIDENCE OF ANY INJURY WAS OBSERVED. THEN THE ROBOT WAS DOCKED AND THE PROCEDURE WAS PERFORMED. THERE WAS NO REPORT THAT A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE PROCEDURE. THE PLANNED SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS STATED IN THE OP REPORT THAT AFTER THE SYSTEM WAS UNDOCKED FROM THE PATIENT, THERE WAS NO EVIDENCE OF INJURY OR BLEEDING OBSERVED. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. REPORTEDLY, ON (B)(6) 2012, THE PATIENT UNDERWENT A PELVIC AND ABDOMINAL CT SCAN, WHICH SHOWED EVIDENCE OF A LOCULATED COLLECTION OF FLUID THAT CONTAINED SOME AIR IN THE ANTERIOR ASPECT OF THE LOWER ABDOMEN/PELVIS. THE FINDINGS SUGGESTED AN INFLAMMATORY PROCESS INVOLVING THE SMALL BOWEL LOOPS. ON (B)(6) 2012, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY AND RESECTION OF THE JEJUNUM WITH PRIMARY STAPLED ANASTOMOSIS. ACCORDING TO THE OP REPORT FOR THIS PROCEDURE, THERE WERE NOTED TO BE TWO MARKS ON THE OMENTUM, ONE OF WHICH PERFORATED THROUGH THE JEJUNUM. AFTER COMPLETION OF THE SURGICAL PROCEDURE, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) IN CRITICAL, BUT STABLE CONDITION AND INTUBATED. ACCORDING TO THE PATIENT'S MEDICAL RECORDS, POST-OPERATIVELY, THE PATIENT WAS CLINICALLY IMPROVING. A CT SCAN ON (B)(6) 2012 SHOWED NO EVIDENCE OF ABSCESS, LEAK, OR FREE AIR. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2012. ON (B)(6) 2013, THE PATIENT UNDERWENT A SURGICAL PROCEDURE FOR REDUCTION AND TAKEDOWN OF ADHESIONS AND MESH REPAIR OF MULTIPLE INCARCERATED INCISIONAL HERNIAS. REPORTEDLY, THERE WERE NO INTRA-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. PER THE MEDICAL RECORDS, ON (B)(6) 2012, THE PATIENT PRESENTED TO THE HOSPITAL'S EMERGENCY ROOM COMPLAINING OF ABDOMINAL PAIN. AN X-RAY PERFORMED SHOWED NO EVIDENCE OF BOWEL OBSTRUCTION. THE PATIENT'S ELECTROLYTES WERE MONITORED OVER HER HOSPITAL ADMISSION, ALL WERE WITHIN NORMAL LIMITS. THE PATIENT'S VITAL SIGNS REMAINED STABLE THROUGHOUT THE PATIENT'S ADMISSION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012 IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474634 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R DA VINCI SI SURG SYS, INSTRUMENTS, ACCESS & ESU