BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5 MM MONOPOLAR CAUTERY INSTRUMENT

    MDR report key: 2823404 · Received November 7, 2012

    Report

    Report Number
    2955842-2012-00826
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 8, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. COMPLAINT OF INSULATION DAMAGED AT THE DISTAL END IS CONFIRMED. BLACK TUBE INSULATION IS DAMAGED AT THE DISTAL END. INSULATION HAS A .125 LONG PIECE MISSING ALL ALONG THE CIRCUMFERENCE OF THE TUBE, STARTING DIRECTLY ABOVE THE SNAKE WRIST. DISTAL END ALSO EXHIBITS SECTIONS LIFTED UP WITH NO MATERIAL REMOVAL ROUGHLY .600 ABOVE THE SNAKE WRIST. 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.

    Description of Event or Problem · 1

    IT WAS OBSERVED DURING CENTRAL PROCESSING THAT THE 5MM MONOPOLAR CAUTERY INSTRUMENT HAD DAMAGE TO THE INSULATION AT THE DISTAL END OF THE INSTRUMENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5 MM MONOPOLAR CAUTERY INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420142-04 S10120213 186

    Patients

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