BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3388877 · Received October 4, 2013

    Report

    Report Number
    2955842-2013-04055
    Event Type
    Death
    Date Received
    October 4, 2013
    Date of Event
    April 23, 2012
    Report Date
    September 6, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 05/27/2014, INTUITIVE SURGICAL, INC. (ISI) IDENTIFIED THAT A DUPLICATE MDR WAS SUBMITTED ON (B)(4) 2013 FOR THIS REPORTED EVENT UNDER (PATIENT IDENTIFIER = (B)(6), MFR REPORT 2955842-2013-05407). ADDITIONAL AND CORRECTED INFORMATION FOR THIS REPORTED EVENT WAS PROVIDED TO ISI ON (B)(6) 2013; HOWEVER, IT WAS NOT KNOWN AT THE TIME THAT BOTH MDR'S INVOLVED THE SAME PATIENT AND EVENT. REFER TO PATIENT IDENTIFIER = (B)(6), MFR REPORT 2955842-2013-05407 FOR THE FOLLOWING ADDITIONAL AND CORRECTED INFORMATION: ADDITIONAL INFORMATION: TEXT FROM PATIENT IDENTIFIER = (B)(6), MFR REPORT 2955842-2013-04055: 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 PATIENT'S CAUSE OF DEATH IS ALSO UNKNOWN. 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 AND THEN PASSED AWAY ON (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    BASED ON THE LIMITED INFORMATION PROVIDED, INTUITIVE SURGICAL 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. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT REPORTEDLY EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SI SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    TEXT FROM PATIENT IDENTIFIER = (B)(6), MFR REPORT 2955842-2013-04055: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2012 FOR HIGH RISK ADENOCARCINOMA OF THE PROSTATE AND SUBSEQUENTLY EXPIRED ON (B)(6) 2012. ISI WAS PROVIDED WITH THE DA VINCI OPERATIVE REPORT AND ADDITIONAL INFORMATION INCLUDING READMISSION NOTES AND LAB WORK. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRA-OPERATIVE COMPLICATION; HOWEVER, THE SURGEON EXPERIENCED DIFFICULTY CONTROLLING BLEEDING FROM THE DORSAL VENOUS COMPLEX SO THE DA VINCI SURGICAL PROCEDURE WAS CONVERTED TO AN OPEN LAPAROTOMY. TRANSFUSIONS WERE REQUIRED WITH RBC AND PLATELETS. THE PATIENT'S HEMATOCRIT WAS LOW (27%). SUPERFICIAL VENOUS THROMBOSIS WAS NOTED ON THE RIGHT LESSER SAPHENOUS VEIN. THE PATIENT WAS DISCHARGED ON (B)(6) 2012. THE PATIENT RETURNED TO THE EMERGENCY ROOM AND REPORTED URINE LEAKING AFTER MANIPULATION OF THE CATHETER AT HOME. ON (B)(6) 2012, A DRAINAGE CATHETER WAS PLACED IN ABDOMEN. ON (B)(6) 2012, THE PATIENT DEVELOPED PULSELESS ELECTRICAL ACTIVITY AND COULD NOT BE RESUSCITATED. NO FURTHER INFORMATION WAS PROVIDED. ISI ATTEMPTED TO CONTACT THE SITE'S RISK MANAGEMENT GROUP FOR ADDITIONAL INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI PROSTATECTOMY PROCEDURE ON (B)(6) 2012. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND/OR UNLAWFUL USE, THE PATIENT SUFFERED INJURIES AND DAMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503815 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000, A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| R DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES