BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 2973152 · Received February 21, 2013

    Report

    Report Number
    2955842-2013-00592
    Event Type
    Other
    Date Received
    February 21, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 22, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE ISI FIELD SERVICE ENGINEER (FSE) WAS UNABLE TO REPLICATE THE ISSUE EXPERIENCED BY THE CUSTOMER. DURING THE FSE'S SITE VISIT, HE SPOKE TO THE INITIAL REPORTER OF THIS EVENT. THE INITIAL REPORTER TO THE FSE THAT THE SURGEON EXPERIENCED ISSUES CONTROLLING THE PATIENT SIDE MANIPULATOR (PSM) 1 AND THAT WHEN THE ISSUE OCCURRED, THE PSM WAS BEING USED AT THE END OF ITS RANGE OF MOTION. THE DA VINCI COORDINATOR INDICATED THAT THE SURGICAL STAFF DID NOT RESEAT OR REPLACE THE STERILE ADAPTER TO RESOLVE THE ISSUE, AS THE SURGEON MADE THE DECISION NOT TO TROUBLESHOOT THE ISSUE AND CONVERTED THE PLANNED SURGICAL PROCEDURE TO OPEN. AS A PRECAUTION, THE FSE REPLACED PSM 1 AND THE REMOTE ARM CONTROLLER (RAC). A SINE CYCLE PERFORMED AND A TEST DRIVE OF THE SYSTEM FOUND THAT THE SITE'S DA VINCI SI SURGICAL SYSTEM FUNCTIONED WITHIN SPECIFICATION. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART THAT PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE RAC CONSISTS OF FIVE PRINTED CIRCUIT ASSEMBLY (PCA) BOARDS WHICH OPERATE TOGETHER TO PROVIDE CONTROL OF THE SYSTEM ARMS. THE PSM AND RAC WERE RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING WAS UNABLE TO REPLICATE THE CUSTOMER REPORTED FAILURE MODE WITH THE RETURNED PSM AND RAC. THE PSM INSTALLED ON AN IN-HOUSE IS3000 SYSTEM FOUND THAT THE PSM FUNCTIONED WITHIN SPECIFICATION. THE RAC PASSED FUNCTIONAL TESTING ON AN IN-HOUSE PCA TEST BOARD SYSTEM AND WAS ALSO EXERCISED FOR ONE DAY AND NO SYSTEM ERRORS WERE GENERATED. ON (B)(4) 2013, ISI CONTACTED THE INITIAL REPORTER OF THIS EVENT. THE INITIAL REPORTER INDICATED THAT THE SURGEON WAS UNABLE TO CONTROL PSM 1 AFTER DOCKING THE PATIENT SIDE CART TO THE PATIENT AND THAT THE PROCEDURE WAS COMPLETED USING MINITHORACOTOMY TECHNIQUES. THE INITIAL REPORTER INDICATED THAT THERE WAS NO HARM TO THE PATIENT, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013 AND THAT TO THE BEST OF HER KNOWLEDGE, THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO ANY POST SURGICAL COMPLICATIONS AS A RESULT OF THE REPORTED EVENT. 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 UPPER RIGHT LOBECTOMY PROCEDURE, A PATIENT SIDE MANIPULATOR (PSM) ARM ON THE PATIENT SIDE CART STOPPED WORKING. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77136 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P7

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES