BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3346178 · Received September 12, 2013

    Report

    Report Number
    2955842-2013-03528
    Event Type
    Injury
    Date Received
    September 12, 2013
    Date of Event
    January 23, 2013
    Report Date
    August 16, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    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 HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATION EXPERIENCED BY THE PATIENT. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(4) 2013. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT SUSTAINED A LARGE BOWEL PERFORATION AFTER UNDERGOING A DA VINCI SI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S INJURY IS UNKNOWN.

    Description of Event or Problem · 1

    AS PART OF A LEGAL MEDIATION EFFORT, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2013. THE MEDICAL RECORDS INDICATE THAT THE PATIENT DEVELOPED POST-OPERATIVE COMPLICATIONS. BASED ON THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD PREOPERATIVE DIAGNOSIS OF UTERINE FIBROIDS AND HISTORY OF BREAST CANCER. ACCORDING TO THE OPERATIVE REPORT, THE SURGEON STATED THAT THE SURGICAL STAFF HAD DIFFICULTY WITH VISUALIZATION SINCE THERE WAS A LARGE FIBROID THAT WAS ANTERIOR IN THE LOWER UTERINE SEGMENT. AT THAT POINT, THE 30-DEGREES CAMERA WAS REPLACED WITH A STRAIGHT CAMERA AND VISUALIZATION WAS NOTED AS BEING BETTER. DUE TO THE LARGE SIZE OF THE UTERUS, THE SURGICAL STAFF FACED DIFFICULTIES REMOVING THE UTERUS VAGINALLY. HENCE, AFTER THE VAGINAL CUFF WAS CLOSED, THE DA VINCI SYSTEM WAS UNDOCKED AND THE UTERUS, TUBES, AND OVARIES WERE REMOVED BY LAPAROSCOPIC MORCELLATION. THE PELVIS WAS WELL IRRIGATED AND THE PATIENT HAD GOOD HEMOSTASIS. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. SHE WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013, A DAY AFTER THE SURGERY, AFTER RESOLUTION OF POSTOP NAUSEA AND VOMITING. ACCORDING TO THE MEDICAL RECORDS PROVIDED, THE PATIENT NOTICED BROWN DISCHARGE FROM HER VAGINA ON (B)(6) 2013. THE PATIENT WAS ADMITTED TO A HOSPITAL THE FOLLOWING DAY. ON (B)(6) 2013, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, REPAIR OF THE VAGINAL CUFF, AND COLOSTOMY. ON (B)(6) 2013, A CT SCAN WITH ORAL CONTRAST OF THE PATIENT'S ABDOMEN AND PELVIS REVEALED NO CONTRAST LEAKAGE OR DEFINED COLLECTION/ABSCESSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458244 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R DA VINCI S SURG SYS INST., ACCESSORIES, & ESU