BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3024191 · Received March 27, 2013

    Report

    Report Number
    2955842-2013-00975
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 25, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER (FSE) DETERMINED THAT THE ARTICULATION ISSUE EXPERIENCED BY THE SITE WAS RELATED TO THE PATIENT SIDE MANIPULATOR ARM 1. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART, WHICH PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED PSM. THE PSM WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING CONFIRMED THE CUSTOMER REPORTED PROBLEM AND FOUND THAT THE WRIST OUTPUT ASSEMBLY POST HEIGHTS OF AXIS 4 THROUGH AXIS 7 ON THE PSM WERE OUT OF SPECIFICATION, THUS CAUSING THE ISSUE EXPERIENCED BY THE SITE. THE PSM WAS REPAIRED BY REPLACING THE AFFECTED OUTPUT ASSEMBLY POSTS. ENGINEERING EVALUATION ALSO FOUND THAT DURING FUNCTIONAL TESTING OF THE PSM, THE PSM FAILED AN IN-HOUSE BRAKE DROP TEST AND AXIS 5 AND AXIS 6 POTENTIOMETERS HAD JITTER. THE MAIN BRAKES AND ALL OF THE POTENTIOMETERS WERE ALSO REPLACED IN THE PSM. ON (B)(4) 2013, ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE WHO INITIALLY REPORTED THE PATIENT INJURY. THE CSR INDICATED THAT THE SURGEON INDICATED TO HIM THAT DAMAGE TO THE PATIENT'S VENA CAVA WAS NOT CAUSED BY A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES; BUT RATHER HE (SURGEON) ACCIDENTALLY NICKED THE PATIENT'S VENA CAVA. PER THE CSR, THE SURGEON STATED I ACCIDENTALLY GOT INTO THE PATIENT'S VENA CAVA. PER THE CSR, THE SURGEON INDICATED THAT THE ARTICULATION ISSUES WITH THE PSMS OCCURRED WHILE ATTEMPTING TO REPAIR THE PATIENT'S ANATOMY. THE CSR INDICATED THAT THE SURGEON ALSO REPORTED TO HIM THAT THE PATIENT IS RECOVERING WELL AND THAT THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST SURGICAL COMPLICATIONS AS A RESULT OF THE REPORTED EVENT. AS OF (B)(4) 2013, THERE HAVE BEEN NO REPORTED RECURRENCES OF THIS FAILURE MODE AT THIS HOSPITAL. THIS REPORT DOES NOT ADMIT THAT THE REPORT OR INFORMATION SUBMITTED UNDER THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, INTUITIVE SURGICAL OR INTUITIVE SURGICAL EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI PARTIAL NEPHRECTOMY PROCEDURE, THE PATIENT SIDE MANIPULATOR ARM 1 BEHAVED IN A SLUGGISH MANNER. THE SITE CONTACTED ISI TECHNICAL SUPPORT ENGINEERING AND INDICATED THAT THEY TROUBLESHOT THE ISSUE BY INSTALLING DIFFERENT INSTRUMENTS ONTO TO THE AFFECTED PSM; HOWEVER, THE ISSUE PERSISTED. THE OR NURSE INDICATED TO THE TSE THAT THEY WERE NOT VERY DEEP INTO THE PATIENT AND THAT THEY COULD NOT OBSERVE ANY INTERFERENCE WITH THE INSTRUMENT OR PSM. THE SITE DECLINED FURTHER TROUBLE-SHOOTING ASSISTANCE AND INDICATED THAT THEY WERE GOING TO PROCEED WITH THE PROCEDURE. ON (B)(4) 2013, THE ISI CLINICAL SALES REPRESENTATIVE FOLLOWED UP WITH THE SURGEON CONCERNING THE REPORTED EVENT. THE CSR INDICATED THAT THE SURGEON INDICATED TO HIM THAT THE PATIENT'S VENA CAVA WAS DAMAGED EARLIER IN THE PROCEDURE AND DURING REPAIR OF THE PATIENT'S ANATOMY, HE EXPERIENCED ARTICULATION ISSUES WITH THE INSTRUMENTS INSTALLED ON THE 1 PSM AND THE 2 PSM. THE CSR INDICATED THAT THE SURGICAL STAFF TROUBLESHOT THE ISSUE BY RESEATING THE INSTRUMENTS AND THE STERILE ADAPTERS. HOWEVER, THE INSTALLED INSTRUMENTS INTERMITTENTLY FAILED TO ARTICULATE PROPERLY. THE CSR INDICATED THAT THE SURGEON REPORTED THAT DUE TO THE PATIENT'S BLEEDING HE WAS UNABLE TO TROUBLESHOOT THE ISSUE FURTHER. THE CSR INDICATED THAT THE SURGEON INDICATED TO HIM THAT DAMAGE TO THE PATIENT'S VENA CAVA WAS REPAIRED USING THE DA VINCI SI SURGICAL SYSTEM AND THAT THE PLANNED SURGICAL PROCEDURE WAS ALSO COMPLETED WITH THE SYSTEM. THE CSR INDICATED THAT THE SITE REPORTED THAT THEY OBSERVED THAT ONE OF THE INNER AXIS INSERTION POSTS LOCATED ON THE 1 PSM WAS PROTRUDING OUT AND WAS NOT FLUSH. NO OTHER DETAILS CONCERNING THIS OBSERVATION WERE PROVIDED TO THE CSR BY THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125908 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A60.P6

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DA VINCI SI SURG. SYS., INSTRUMENTS & ACCESSORIES