BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 3665111 · Received March 6, 2014

    Report

    Report Number
    2955842-2014-01365
    Event Type
    Injury
    Date Received
    March 6, 2014
    Date of Event
    November 17, 2004
    Report Date
    January 13, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 08/11/2014,INTUITIVE SURGICAL, INC. (ISI) OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. DURING THE CASE THERE WAS A REPORT OF AN ERROR CODE 20105, WHICH INDICATES A SELF-TEST ERROR FOR A COMPUTE ENGINE (CE) NODE AND IS TRIGGERED WHEN A BUS REFERENCE VOLTAGE IS OUT OF RANGE. THIS ERROR MESSAGE WOULD REQUIRES A SYSTEM RESTART TO CLEAR. DUE TO ROBOT FAILURE THE PROCEDURE WAS COMPLETED VIA CONVENTIONAL LAPAROSCOPIC. IT IS NOT CLEAR WHEN THE REPORTED BLADDER LACERATION OCCURRED. PERTINENT FINDINGS INCLUDE: ADHESIONS AND OBESITY. IN ADDITION, PER THE MEDICAL RECORDS, THE PATIENT WAS INFORMED THAT THE SURGERY WOULD BE MORE DIFFICULT DUE TO HIS OBESITY. THE OPERATIVE FINDINGS STATE, THERE WAS EXTENSIVE SCARRING ON THE RIGHT SIDE BETWEEN THE NEUROVASCULAR BUNDLE AND THE RIGHT PROSTATE. ON THE LEFT SIDE, THERE WAS LESS SCARRING; HOWEVER, THERE WAS STILL ADHESION BETWEEN THE PERIPROSTATIC TISSUES AND THE PROSTATE. IN THE PROCEDURE SECTION, THE OPERATIVE REPORT STATES, THERE WAS SEEN TO BE EXTENSIVE ADHESIONS ON THE RIGHT SIDE AND THE NEUROVASCULAR BUNDLE WAS NOT COMING OFF AT ALL. THEREFORE, AN ENDOSCOPIC STAPLING DEVICE WAS THEN USED TO DIVIDE THE PEDICLE ON THE RIGHT SIDE. ATTEMPTS AT MOBILIZING THE LEFT NEUROVASCULAR BUNDLE WERE ALSO DIFFICULT AND CLIPS WERE USED; HOWEVER, THERE WAS AGAIN EXTENSIVE SCARING. THE APEX OF THE PROSTATE WAS DIVIDED AND THE PROSTATE WAS FREED AND PLACED IN A 10 MM ENDOCATCH BAG AND LEFT IN THE ABDOMEN. DURING EVALUATION OF THE BLADDER, THERE APPEARED TO BE A LARGE BLADDER LACERATION ANTERIORLY AND THIS APPEARED TO BE DUE TO THE DAVINCI ROBOT FAILURE. THE ANTERIOR BLADDER LACERATION WAS CLOSED WITH 2-0 POLYSORB SUTURE IN A RUNNING FASHION AND THE REPAIR APPEARED TO BE WATER TIGHT. THE ANASTOMOSIS WAS THEN PERFORMED USING RUNNING 2-0 POLYSORB SUTURE. THE PATIENT WAS DISCHARGED ON POST OPERATIVE DAY (POD)2 WITH A DRAIN IN PLACE AS WELL AS A FOLEY CATHETER.

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE MALFUNCTION OF THE DA VINCI SYSTEM. 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. NO SYSTEM LOG WAS AVAILABLE FOR REVIEW. THIS COMPLAINT IS BEING REPORTED SINCE THE REPORT ALLEGES THAT THERE WAS A BLADDER LACERATION DUE TO A MALFUNCTION OF THE DA VINCI SYSTEM. IT IS UNKNOWN AT THIS TIME HOW THE DA VINCI SYSTEM MALFUNCTIONED AND CAUSED THE LACERATION.

    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 PROSTATECTOMY PROCEDURE ON (B)(6) 2004 AND DURING THE PROCEDURE IT WAS NOTED THAT THERE WAS BLEEDING DUE TO POOR FUNCTION OF THE STAPLER.(NON ISI DEVICE) . IT WAS ALSO NOTED THAT THE PATIENT HAD A BLADDER LACERATION WHICH APPEARED TO BE DUE TO THE DA VINCI ROBOT FAILURE. ACCORDING TO THE OPERATIVE REPORT THE FOLLOWING WAS NOTED:THERE WAS EXTENSIVE SCARRING ON THE RIGHT SIDE BETWEEN THE NEUROVASCULAR BUNDLE AND THE RIGHT PROSTATE. ON THE LEFT SIDE, THERE WAS LESS SCARRING; HOWEVER, THERE WAS STILL ADHESION BETWEEN THE PERIPROSTATIC TISSUES AND THE PROSTATE. DURING THE PROCEDURE, THE DAVINCI ROBOT FAILED AND THE PROCEDURE HAD TO BE COMPLETED WITH CONVENTIONAL LAPAROSCOPY. THE VESICOURETHRAL ANASTOMOSIS WAS PERFORMED; HOWEVER, THERE WAS SOME LEAKING FROM THE POSTERIOR ASPECT AT THE END OF THE OPERATION. THE ENDOSCOPIC STAPLING DEVICE WAS BROUGHT IN AND THIS WAS USED TO DIVIDE THE DORSAL VENOUS COMPLEX. THERE WAS SEEN TO BE SOME BLEEDING, HOWEVER, WITH WHAT APPEARED TO BE POOR FUNCTION OF THE STAPLER. THE DORSAL VENOUS COMPLEX WAS THEN OVERSEWN CONTROLLING THE BLEEDING. THE PROSTATE BLADDER NECK JUNCTION WAS IDENTIFIED AND THIS WAS TAKEN DOWN CAREFULLY WITH CAUTERY. THE LATERAL SURFACES WERE CAREFULLY DISSECTED. THE POSTERIOR BLADDER NECK WAS THEN DISSECTED AS WELL AS THE VAS DEFERENS AND SEMINAL VESICLES. IT WAS AT THIS POINT THAT THE DAVINCI ROBOT FAILED AND THE ROBOT WAS REMOVED AND THE ESOP VOICE-ACTIVATED ROBOT WAS BROUGHT IN AND PLACED ON THE BED RAIL ON THE RIGHT SIDE NEAR THE PATIENT'S HEAD. LAPAROSCOPIC INSTRUMENTS WERE REPLACED AND DISSECTION OF THE SEMINAL VESICLES WAS COMPLETED. THERE WAS SEEN TO BE EXTENSIVE ADHESIONS ON THE RIGHT SIDE AND NEUROVASCULAR BUNDLE WAS NOT COMING OFF AT ALL. DURING THE EVALUATION OF THE BLADDER, THERE APPEARED TO BE A LARGER BLADDER LACERATION ANTERIORLY AND THIS APPEARED TO BE DUE TO THE DAVINCI ROBOT FAILURE. THE STAPLER USED IN THIS PROCEDURE WAS A NON-ISI PRODUCT. THE ISI STAPLER WAS FIRST INTRODUCED TO THE MARKET IN 2013 AND THE STAPLER USED IN THIS PROCEDURE WAS USED IN 2004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136380 DA VINCI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention