BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3551608 · Received January 3, 2014

    Report

    Report Number
    2955842-2014-00038
    Event Type
    Injury
    Date Received
    January 3, 2014
    Date of Event
    December 6, 2013
    Report Date
    December 6, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PSM WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING WAS UNABLE TO REPLICATED THE CUSTOMER REPORTED INTERMITTENT DELAY AND NON-INTUITIVE MOTION WITH THE PSM ARM. THE PSM PASSED PRE-TEST, SINE CYCLE, FRICTION TESTS, AND NORMAL MODE TESTING WITH VARIOUS TEST INSTRUMENTS, CANNULAE, AND STERILE ADAPTORS. ALL FOUR INNER AXES PASSED FRICTION AND HAD FULL RANGE OF MOTION. IN NORMAL MODE, ENGINEERING OBSERVED THE JAWS OF THE INSTRUMENTS, AND THE MOVEMENTS WERE INTUITIVE FROM THE MASTERS WITH NO HESITANCY. VISUAL INSPECTION FOUND NOTHING UNUSUAL. THE FLEX CABLE AND CONNECTORS WERE INTACT AND UNDAMAGED. UNRELATED TO THE CUSTOMER REPORTED FAILURE MODE, ENGINEERING INDICATED THAT THE PSM ARM FAILED AN IN-HOUSE BRAKE DROP TEST. ISI HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S COMMON BILE DUCT WAS REPORTEDLY NICKED DURING THE DA VINCI CHOLECYSTECTOMY PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT INJURY IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI CHOLECYSTECTOMY PROCEDURE, THE SURGEON EXPERIENCED REPEATED INTERMITTENT DELAY AND NON-INTUITIVE MOTION WITH PATIENT SIDE MANIPULATOR ARM 2 (PSM2). THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART (PSC) THAT PROVIDES STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENT. IT WAS REPORTED THAT THE PATIENT'S COMMON BILE DUCT WAS NICKED. HOWEVER, THE SURGEON STATED THAT THE INJURY TO THE PATIENT'S COMMON BILE DUCT WAS NOT RELATED TO THE PSM2 ISSUES. ON (B)(4) 2013, AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER(FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE TESTED THE PSM INVOLVED WITH THIS COMPLAINT AND FOUND THE PSM SENSORS WERE FUNCTIONING PROPERLY. THE FSE WAS UNABLE TO REPLICATE THE REPORTED ISSUE. THE FSE REVIEWED THE SYSTEM LOGS AND FOUND MULTIPLE 282 AND 31009 ERROR CODES. AN ERROR CODE 282 INDICATES THAT A TOOL WAS DETERMINED TO BE INVALID BY THE SYSTEM. AN ERROR CODE 31009 INDICATES TOOL WAS FULLY DETECTED, AND THEN ONE OR MORE (BUT NOT ALL) OF THE TOOL SENSORS WERE NOT DETECTED FOR 3 SECONDS. THE FSE EXPLAINED THAT THE REPORTED PSM ISSUES WERE MOST LIKELY RELATED TO AN ISSUE WITH THE STERILE ADAPTER. HOWEVER THE INITIAL REPORTER, AN ISI CLINICAL SALES REPRESENTATIVE (CSR), STATED THAT THE SURGICAL STAFF RESEATED AND REPLACED THE STERILE ADAPTER DURING THE SURGICAL PROCEDURE AND ALSO TRIED MULTIPLE INSTRUMENTS. THE CSR INDICATED THAT THE PSM ISSUES PERSISTED. THE FSE REPLACED THE PSM AS A PRECAUTIONARY MEASURE. THE FSE TESTED THE SYSTEM AND VERIFIED THAT THE SYSTEM WAS READY FOR USE. ON (B)(4) 2013, ISI CONTACTED THE CSR. HE STATED THAT HE WAS AT THE HOSPITAL WHEN THE EVENT OCCURRED BUT WAS NOT IN THE OPERATING ROOM (OR). HE CONFIRMED THAT THE SURGEON INFORMED HIM THAT THE INJURY TO THE PATIENT'S COMMON BILE DUCT WAS NOT RELATED TO THE PSM2 ISSUES. THE CSR DID NOT KNOW ANY DETAILS OF HOW THE INJURY TO THE PATIENT'S COMMON BILE DUCT OCCURRED. THE CSR STATED THAT THE SURGEON INFORMED HIM THAT THE PATIENT WAS DOING WELL 1-3 DAYS POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3762 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening