BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGASUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 2851805 · Received November 29, 2012

    Report

    Report Number
    2955842-2012-01114
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 26, 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
    MT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT ONE GRIP CABLE IS BROKE AT THE DISTAL IDLERS. THE IDLER PULLEY SPINS FREELY AND WAS NOT DAMAGED. THE CABLE SEGMENT STICKS OUT AT THE WRIST. 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 DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE WIRES ON THE MEGASUTURECUT NEEDLE DRIVER INSTRUMENT FRAYED. THERE WERE NO MISSING OR FALLEN PIECES REPORTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEGASUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10110625 423

    Patients

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