BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3443502 · Received November 1, 2013

    Report

    Report Number
    2955842-2013-04891
    Event Type
    Death
    Date Received
    November 1, 2013
    Date of Event
    April 6, 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 OPERATIVE REPORTS 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 AND EXPIRED AFTER UNDERGOING A DA VINCI S SURGICAL PROCEDURE. NO OBVIOUS CORRELATION BETWEEN THE USE OF THE DAVINCI INSTRUMENT AND THE PATIENT'S SUBSEQUENT COMPLICATIONS AND DEATH.

    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 S TOTAL HYSTERECTOMY WITH LYMPHADENECTOMY FOR ADENOCARCINOMA OF THE ENDOMETRIUM (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT . ADDITIONAL INFORMATION PROVIDED INCLUDES OFFICE AND HOSPITAL NOTES REGARDING FOLLOW UP CARE. 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. ON (B)(6) 2012 THE PATIENT UNDERWENT RADICAL HYSTERECTOMY WITH BSO, RIGHT PELVIC LYMPH NODE BIOPSY AND APPENDECTOMY ON. DISCHARGED ON (B)(6) 2012. RE-ADMISSION ON (B)(6) 2012 FOR EXPLORATORY LAPAROTOMY FOR PELVIC ABSCESS WITH SEPTIC SHOCK. LARGE 8-10 CM POSTERIOR ABSCESS NOTED. NO INTESTINAL PERFORATION OR OTHER INJURY WAS NOTED. UNFORTUNATELY, FOLLOWING SURGERY, SHE EXPIRED DUE TO SEPTIC CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563325 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death| R DA VINCI SI SYSTEM INSTRUMENTS, ACCESSORIES & ESU