BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST ONE VESSEL SEALER

    MDR report key: 4865255 · Received June 24, 2015

    Report

    Report Number
    2955842-2015-00929
    Event Type
    Malfunction
    Date Received
    June 24, 2015
    Date of Event
    May 29, 2015
    Report Date
    May 29, 2015
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K140189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSIONS: THE VESSEL SEALER INSTRUMENT NOT SEALING COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF THE MALFUNCTION WERE TO RECUR.

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. ATTEMPTED TO SUBMIT THIS MDR ON TIME; HOWEVER, THIS MDR WAS SUBMITTED ON 08/11/2015, WHICH IS PAST THE DUE DATE DUE TO FDA'S SCHEDULED MAINTENANCE. FROM AUGUST 6 TO 10, 2015, THE FDA'S ELECTRONIC MEDICAL DEVICE REPORTING (EMDR) SYSTEM WAS UNDERGOING SCHEDULED MAINTENANCE. DURING THIS TIME, THE FDA WAS NOT ACCEPTING MEDICAL DEVICE REPORTS (MDRS) ELECTRONICALLY. DEVICE EVALUATION AND ADDITIONAL INFORMATION CAN BE FOUND IN FOLLOWING SECTIONS: INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS FOUND THAT THE INSTRUMENT PASSED SELF CHECK UPON INSTALLING THE INSTRUMENT ON AN IN-HOUSE SYSTEM. THE GRIP FORCE TEST, ELECTRICAL CONTINUITY TEST, ENERGY DELIVERY, INTUITIVE MOTION AND RECOGNITION AND ENGAGEMENT TEST ALL PASSED. THE INSTRUMENT FAILED THE GAP CLEARANCE SPECIFICATION BETWEEN THE ELECTRODES. BASED ON THE FAILED TEST, THE INSTRUMENT WOULD HAVE TROUBLE SEALING ON SMALL VESSELS OR THIN TISSUE BUNDLES. ISI ALSO RECEIVED A VIDEO OF THE PROCEDURE WHICH WAS REVIEWED BY ADVANCED ENGINEERING. REVIEW OF THE VIDEO INDICATED THAT THE USER WAS SEALING ONTO A METAL STAPLE, WHICH INDICATES A MISUSE. THE USER MANUAL PROVIDES PRECAUTIONS FOR INTRAOPERATIVE USE: DO NOT TOUCH THE JAWS TO ANY CLIPS, SUTURES, STAPLES OR OTHER METAL OBJECTS WHILE ENERGIZED. THIS MAY COMPROMISE THE SEAL AND MAY DAMAGE THE JAWS. BASED ON THE ADDITIONAL INFORMATION, THIS COMPLAINT REMAINS REPORTABLE BECAUSE THE RETURNED DEVICE FAILED THE GAP CLEARANCE SPECIFICATION, WHICH POTENTIALLY CAN LEAD TO SEALING ISSUES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI RIGHT HEMICOLECTOMY PROCEDURE, THE ENDOWRIST ONE VESSEL SEALER INSTRUMENT HAD NO ENERGY THERE WAS NO PATIENT INJURY OR HARM AND THERE WERE NO REPORTS OF FRAGMENT(S) FALLING INTO THE PATIENT. ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) OBTAINED FOLLOWING ADDITIONAL INFORMATION ABOUT THE COMPLAINT: ISI CLINICAL SALES REP (CSR) INDICATED THAT THE VESSEL SEALER INSTRUMENT WORKED AT THE BEGINNING OF THE CASE AND THEN IT STOPPED WORKING. ACCORDING TO THE CSR, SURGEON WAS AWARE OF INSTRUMENT NOT SEALING BY VISUAL CUES ONLY, SURGEON DID NOT SEE HEAT COMING OUT OF THE VESSEL SEALER INSTRUMENT OR TISSUE SEALING. THE INSTRUMENT SEEMED TO TAKE A LONG TIME TO BEEP AND SOMETIMES, THERE WERE NO BEEPS. THE SYSTEM DID NOT GIVE ANY ERROR MESSAGES. ACCORDING TO THE CSR, SOME OF THE SEALING CYCLES WERE OVER 20 SECONDS. PROCEDURE WAS COMPLETED ROBOTICALLY. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408454 ENDOWRIST ONE VESSEL SEALER ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 480322-05 S10150330 0004

    Patients

    Seq Age Sex Outcome Treatment
    1