BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CAUTERY INSTRUMENT

    MDR report key: 2840879 · Received November 20, 2012

    Report

    Report Number
    2955842-2012-01006
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 24, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING OBSERVED MAIN TUBE INSULATION SCRATCHES AND GOUGE MARKS, WITH A PIECE APPROXIMATELY 0.06 X 0.03 REMOVED. EVIDENCE IS NOT CONCLUSIVE, BUT DAMAGE IS LIKELY DUE TO EXCESS FORCE CONTACT ON THE MAIN TUBE SURFACE. THE INSTRUMENT HAS 14 USES REMAINING. UPON FOLLOW UP WITH THE CUSTOMER REGARDING FAILURE ANALYSIS FINDINGS, IT WAS STATED THAT NO PIECES WERE OBSERVED FALLING INTO THE PATIENT AT THE TIME OF SURGERY. NO FURTHER INFORMATION WAS AVAILABLE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SETUP FOR A DA VINCI SI SURGICAL PROCEDURE, IT WAS NOTED THAT MONOPOLAR CAUTERY INSTRUMENT'S INSULATION WAS CUT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR CAUTERY INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420142-04 S10111119 333

    Patients

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