BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST ONE VESSEL SEALERINSTRUMENT

    MDR report key: 3791154 · Received May 5, 2014

    Report

    Report Number
    2955842-2014-02787
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    March 14, 2014
    Report Date
    April 7, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K110639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THE INSTRUMENT'S BLADE DISLODGED. THE BLADE WAS EXPOSED APPROXIMATELY .091 BETWEEN GRIPS. THE BLADE AND BLADE TRACK LOOKED FREE OF BIODEBRIS. THE INSTRUMENT WAS PLACED ON A SYSTEM AND FAILED HOMING. ADDITIONAL, THE BLADE WAS BENT. THE KNIFE BLADE WAS PULLED OUT OF THE GARAGE FOR INSPECTION AND IT WAS FOUND BENT AT THE KNIFE AND CABLE INTERFACE. AN ADDITIONAL OBSERVATION NOT REPORTED WAS THE SNAKE WRIST WAS DISLODGED. THE TEETH THAT MATE WITH EACH OTHER DID NOT SIT PROPERLY, CAUSING THE WRIST TO BE DISLODGED. NO OTHER DAMAGE WAS FOUND. THE INSTRUMENT WAS UNABLE TO TESTED DUE TO THE WRIST BEING DISLODGED. LOG FILE DATA SHOWED THE INSTRUMENT WAS USED PROPERLY AND WAS REINSTALLED 4 SEPARATE TIMES AND THEN HAD 1 BLADE JAM ERROR. THE INSTRUMENT WAS THEN REINSTALLED 3 CONSECUTIVE TIMES AND HAD A HOMING FAILED ERROR. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE DISLODGED SNAKE WRIST, FOUND DURING FAILURE ANALYSIS EVALUATION COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI RADICAL CYSTECTOMY PROCEDURE, SUDDEN ERROR WITH NOTION: `BLADE CAN BE UNPROTECTED`. AFTER REMOVAL AND RESTART GENERATOR, THERE WAS NO CALIBRATION POSSIBLE AND INSTRUMENT WAS NOT USEABLE ANY MORE. A NEW INSTRUMENT WAS USED. NOTHING REPORTEDLY FELL INTO A PATIENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268904 ENDOWRIST ONE VESSEL SEALERINSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 410322-04 M10131122 224

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR