BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUCTION / IRRIGATOR INSTRUMENT

    MDR report key: 2871116 · Received December 12, 2012

    Report

    Report Number
    2955842-2012-01286
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    August 28, 2012
    Report Date
    September 13, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K110451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. COMPLAINT OF THE TIP ALMOST CAME OFF IS CONFIRMED. INSTRUMENT WAS RETURNED WITH ALL THE DISTAL END CABLES CUT AND THE SNAKE WRIST AND TIP ASSEMBLY DETACHED FROM THE MAIN TUBE. SNAKE WRIST DISKS ARE NOT IN ALIGNMENT. EVIDENCE NOT CONCLUSIVE, BUT LIKELY FAILURE WAS A DISLODGED SNAKE WRIST DISK. WRIST CABLES WERE LIKELY CUT TO ENABLE REMOVAL OF INSTRUMENT FROM CANNULA. 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 REPORTED THAT PRIOR TO STARTING A DA VINCI SI LOBECTOMY PROCEDURE, THE SURGICAL STAFF REPORTED THAT THE TIP OF THE SUCTION IRRIGATOR INSTRUMENT ALMOST CAME OFF. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUCTION / IRRIGATOR INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 410299-02 M10120510 183

    Patients

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