BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3133834 · Received May 29, 2013

    Report

    Report Number
    2955842-2013-01867
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER (FSE) WAS UNABLE TO REPLICATE THE FAILURE MODE EXPERIENCED BY THE CUSTOMER. THE FSE TESTED THE PATIENT SIDE MANIPULATOR (PSM) ARM 1 USING ALL OF THE INSTRUMENTS THAT WERE USED DURING THE SURGICAL PROCEDURE. THE STERILE ADAPTER USED DURING THE SURGICAL PROCEDURE WAS NOT TESTED, AS THE SITE HAD ALREADY DISCARDED THE STERILE ADAPTER. ALL OF THE INSTRUMENTS PASSED RECOGNITION TESTING AND WERE READY FOR FOLLOW ON MATCHING GRIP MODE. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART THAT PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENT. PSM 1 WAS REPLACED AS A PRECAUTION. ON (B)(4) 2013 INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER REGARDING THE REPORTED EVENT. THE INITIAL REPORTER INDICATED THAT THE SURGEON EXPERIENCED NON-INTUITIVE MOVEMENT ON PSM 1 WHILE USING A PROGRASP INSTRUMENT AND NEEDLE DRIVER INSTRUMENT AND THAT THE SURGICAL STAFF RESEATED THE STERILE ADAPTER AND REPLACED THE INSTRUMENTS, HOWEVER, THE ISSUE PERSISTED. THE INITIAL REPORTER INDICATED THAT THE PATIENT'S VESSELS WERE CROSS CLAMPED APPROXIMATELY 42 MINUTES. THE INITIAL REPORTER INDICATED THAT THE PATIENT TOLERATED THE PROCEDURE WELL AND TO THE BEST OF HER KNOWLEDGE THE PATIENT HAS NOT YET PRESENTED ANY SYMPTOMS OF KIDNEY DAMAGE. ON (B)(4) 2013, THE ISI CLINICAL SALES REPRESENTATIVE WHO WAS PRESENT DURING THE SURGICAL PROCEDURE REPORTED THAT SHE SPOKE TO THE SURGEON AFTER COMPLETION OF THE SURGICAL PROCEDURE AND THE SURGEON INDICATED TO HER THAT HE FELT THAT THE PROCEDURE WENT WELL. PSM 1 WAS RETURNED TO ISI FOR FAILURE ANALYSIS EVALUATION. ENGINEERING WAS UNABLE TO REPLICATE THE FAILURE MODE EXPERIENCED BY THE CUSTOMER AS FUNCTIONAL TESTING OF THE PSM ON AN IN-HOUSE IS3000 TEST SYSTEM USING ISI IN-HOUSE TEST INSTRUMENTS FOUND THAT THE PSM FUNCTIONED WITHIN SPECIFICATIONS. AS OF (B)(4) 2013, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI PARTIAL NEPHRECTOMY PROCEDURE, THE SURGEON EXPERIENCED NON-INTUITIVE MOTION ON PATIENT SIDE MANIPULATOR (PSM) ARM 1 WHILE MANIPULATING THE RIGHT MASTER TOOL MANIPULATOR (MTM) ON THE SURGEON SIDE CART (SSC). THE SITE RESEATED THE STERILE ADAPTER AND INSTRUMENT; HOWEVER, THE ISSUE PERSISTED. THE SITE CONTACTED INTUITIVE SURGICAL, INC. TECHNICAL SUPPORT ENGINEERING (TSE) TO REPORT THE ISSUE. THE TSE ATTEMPTED TO HELP THE SITE TROUBLESHOOT THE ISSUE; HOWEVER, AT THE TIME OF THE CALL, THE SURGEON DECLINED TO TROUBLESHOOT THE ISSUE AS THE PATIENT'S VESSELS WERE CROSS CLAMPED AND THE CROSS CLAMP TIME WAS EXTENDED AS A RESULT OF THE REPORTED FAILURE MODE. THE SURGICAL STAFF INDICATED TO THE TSE THAT THE SURGEON STATED THAT THERE WAS A POSSIBILITY THAT THE PATIENT MAY HAVE SUSTAINED KIDNEY DAMAGE DUE TO THE EXTENDED CROSS CLAMP TIME. THE TSE ASKED THE SITE IF THE SURGEON HAD CONSIDERED COMPLETING THE SURGICAL PROCEDURE USING OPEN SURGICAL TECHNIQUES; HOWEVER, THE SURGICAL STAFF INDICATED THAT CONVERSION OF THE PROCEDURE TO OPEN HAD NOT BEEN CONSIDERED. REVIEW OF THE SITE'S SYSTEM LOGS BY THE TSE FOUND THAT AN INVALID TOOL ERROR OCCURRED WITH THE INSTALLATION OF THREE DIFFERENT INSTRUMENTS ONTO PSM 1. THE SURGEON COMPLETED THE PLANNED SURGICAL PROCEDURE UTILIZING THE LEFT MASTER TOOL MANIPULATOR. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED TO HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235777 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P4

    Patients

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