BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA NEEDLE DRIVER INSTRUMENT

    MDR report key: 2851838 · Received November 29, 2012

    Report

    Report Number
    2955842-2012-01107
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. COMPLAINT OF SNAPPED CABLE WAS CONFIRMED. ONE GRIP CABLE IS BROKEN AT THE DISTAL IDLERS. IDLER PULLEY WAS NOT DAMAGED. CABLE SEGMENT STICKS OUT AT WRIST. NO OTHER CABLE 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 HYSTERECTOMY PROCEDURE, WHILE SUTURING THE SUTURE TAIL WRAPPED AROUND THE NEEDLE HOLDER JAW, THE CABLE INSIDE OF THE MEGA NEEDLE DRIVER INSTRUMENT BROKE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEGA NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420194-08 M10120710 537

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES