BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST ONE VESSEL SEALER INSTRUMNENT

    MDR report key: 3864021 · Received June 10, 2014

    Report

    Report Number
    2955842-2014-03550
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    February 13, 2014
    Report Date
    May 16, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K110639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND BLADE DISLODGED BETWEEN THE GRIPS. THE SELF-TEST WOULD NOT PASS AND THE VESSEL SEALER INSTRUMENT WOULD NOT ENGAGE. NEITHER BLADE CABLE NOR BLADE WAS BENT. THE INSTRUMENT PASSED THE SELF-TEST WITHOUT ANY ERRORS AFTER THE BLADE WAS RE-SEATED. FAILURE ANALYSIS INVESTIGATION ALSO FOUND DISLODGED SNAKE WRIST. THERE WERE NO MISSING PIECES. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM; HOWEVER, IT WOULD NOT ADVANCE THROUGH THE 8 MM CANNULA DUE TO THE DISLODGED SNAKE WRIST. 13 MM STAPLER CANNULA WAS USED TO ADVANCE THE INSTRUMENT AND TO PERFORM VESSEL SEALER CAUTERY FUNCTION. THE CAUTERY FUNCTION WAS PERFORMED WITHOUT ANY ISSUES. THE ELECTRICAL CONTINUITY TEST WAS PERFORMED AND PASSED. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE DISLODGED SNAKE WRIST FOUND DURING FAILURE ANALYSIS COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    ON (B)(4) 2014, INTUITIVE SURGICAL, INC. RECEIVED A MED WATCH FORM (B)(4) FROM THE FDA, WHICH INDICATED THE INTUITIVE SURGICAL ENDOWRIST ONE VESSEL SEALER FAULTED (LIGHT ON ROBOT ARM TURNED YELLOW) DURING THE CASE WITH THE BLADE EXPOSED AND THE SEALER WAS UNABLE TO BE ACTIVATED. THIS WAS A LAPAROSCOPIC ROBOTIC RADICAL PROSTATECTOMY PROCEDURE. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. OBTAINED ADDITIONAL INFORMATION FROM INITIAL REPORTER, WHO INDICATED THAT THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES. THERE WAS NO PATIENT HARM OR INJURY, AND THERE WERE NO REPORTS OF ANYTHING BREAKING OR FALLING INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341004 ENDOWRIST ONE VESSEL SEALER INSTRUMNENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 410322-04 M10131016 338

    Patients

    Seq Age Sex Outcome Treatment
    1