BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST ONE VESSEL SEALERINSTRUMENT

    MDR report key: 3822086 · Received May 20, 2014

    Report

    Report Number
    2955842-2014-03109
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 21, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K110639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS FOUND THE INSTRUMENT BLADES DISLODGED. VISUAL INSPECTION SHOWS THE BLADE WAS EXPOSED 0.63 FROM THE BLADE GARAGE. THE CONDUCTOR WIRE WAS NOT DAMAGED. ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS THE SNAKE WRIST WAS DISLODGED AT THE DISTAL END OF THE INSTRUMENT. AS A RESULT OF THE DISLODGED WRIST, THE INSTRUMENT COULD NOT BE TESTED FOR SEALING OR CUTTING ISSUES SINCE THE INSTRUMENT COULD NOT BE INSERTED INTO THE CANNULA FOR FUNCTIONAL TESTING. NO OTHER DAMAGE WAS FOUND. FAILURE ANALYSIS CONCLUDED THE DISLODGED WRIST WAS LIKELY DUE TO MISHANDLING / MISUSE. THE ENDOWRIST® INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE DISLODGED 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 LOW ANTERIOR RESECTION PROCEDURE, THE ENDO WRIST ONE VESSEL SEALER INSTRUMENT DISPLAYED THE ERROR MESSAGE, CALIBRATION FAILED. 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
    299494 ENDOWRIST ONE VESSEL SEALERINSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 410322-04 M10140116 717

    Patients

    Seq Age Sex Outcome Treatment
    1