BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VESSEL SEALING INSTRUMENT

    MDR report key: 3103606 · Received May 9, 2013

    Report

    Report Number
    2955842-2013-01579
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    March 21, 2013
    Report Date
    April 9, 2013
    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, ENGINEERING OBSERVED THAT TWO ADJACENT DRIVE CABLES WERE STICKING OUT AT THE DISTAL END OF THE SNAKE WRIST. THE INSTRUMENT'S MOTION COULD NO LONGER BE INTUITIVE DUE TO THE BROKEN CABLES. NO OBVIOUS DAMAGE OBSERVED ON SNAKE WRIST DISCS. THE GRIPS AND THE BLADE TRACK EXHIBITED DRIED BIO DEBRIS, BUT BLADE WAS NOT EXPOSED. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI SURGICAL PROCEDURE, THE CUSTOMER NOTED BROKEN AND EXPOSED WIRES ON THE VESSEL SEALER INSTRUMENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204622 VESSEL SEALING INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 410322-04 S10120831 983

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM, ESU, INSTRUMENTS & ACCESSORIE