BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGASUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 2955797 · Received February 11, 2013

    Report

    Report Number
    2955842-2013-00459
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT ONE GRIP CLOSE CABLE WAS BROKEN AT THE DISTAL IDLERS PULLEY. THE IDLER PULLEY SPUN FREELY; HOWEVER IT EXHIBITED DAMAGE ON THE EDGE AND ON THE SURFACE. ENGINEERING CONCLUDED THAT THE DAMAGE WAS LIKELY DUE TO EXCESS FORCE CONTACT AT THE SURFACE AND MISHANDLING. THE CABLE AT THE WRIST ALSO STUCK OUT. THE OTHER CABLES AT THE WRIST DID NOT EXHIBIT DAMAGE. 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 SURGICAL PROCEDURE, IT WAS NOTED THAT THE CABLE THAT CONTROLS MOVEMENT ON THE MEGASUTURECUT NEEDLE DRIVER INSTRUMENT BROKE. 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
    58294 MEGASUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10120216 370

    Patients

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