BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA NEEDLE DRIVER

    MDR report key: 2840881 · Received November 20, 2012

    Report

    Report Number
    2955842-2012-01005
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING OBSERVED THAT THE GRIP CABLE IS FRAYED AT THE DISTAL IDLER PULLEY. THE FRAYED STRANDS STICK OUT AT THE WRIST. OTHER CABLES AT WRIST ARE NOT DAMAGED. ADDITIONALLY, THE INSTRUMENT WAS FOUND WITH FRAYED PITCH CABLE AT DISTAL CLEVIS HUB. NO DAMAGE WAS FOUND AT THE CLEVIS. THE INSTRUMENT HAD 5 USES LEFT. ON (B)(4) 2012, THE REPORTER WAS CONTACTED REGARDING THE CUSTOMER COMPLAINT. IT WAS STATED THAT NO FALLEN PIECES WERE OBSERVED IN THE PATIENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FRAYED WIRE WAS FOUND ON THE MEGA NEEDLE DRIVER INSTRUMENT DURING A DA VINCI S HYSTERECTOMY PROCEDURE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEGA NEEDLE DRIVER ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420194-07 S10090112 485

    Patients

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