BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM MONOPOLAR CAUTERY INSTRUMENT

    MDR report key: 2912365 · Received January 11, 2013

    Report

    Report Number
    2955842-2013-00157
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 13, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K112208
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. COMPLAINT OF THREADS ARE MISALIGNED CANNOT BE CONFIRMED. INSTRUMENT WAS RETURNED WITH THE MONOPOLAR ADAPTER PIECE BROKEN OFF AT THE DISTAL END. THIS PIECE CONTAINS THE THREADS THAT MATE WITH THE DISPOSABLE CAUTERY TIP. MONOPOLAR ADAPTER BROKE OFF AT THE INTERFACE WITH THE METAL WRIST ADAPTER. CONDUCTOR WIRE IS ALSO BROKEN AS A RESULT OF THE ADAPTER BREAKAGE. EVIDENCE NOT CONCLUSIVE, BUT DAMAGE IS LIKELY DUE TO MISHANDLING/MISUSE. NO OTHER DAMAGE FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS - HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. DO NOT USE AN INSTRUMENT TO CLEAN DEBRIS FROM ANOTHER INSTRUMENT INTRAOPERATIVELY. THIS MAY RESULT IN DAMAGE TO THE INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 5MM MONOPOLAR CAUTERY INSTRUMENT HAD MISALIGNED THREADS RIGHT OUT OF THE BOX. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16411 5MM MONOPOLAR CAUTERY INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 428052-06 S10120926 657

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES