BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGASUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 2970785 · Received February 20, 2013

    Report

    Report Number
    2955842-2013-00572
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    December 20, 2012
    Report Date
    January 24, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT ONE CABLE WAS BROKEN AROUND THE GROVE NEAR GRIP. THE BROKEN CABLE SEGMENT STUCK OUT AT THE WRIST, HOWEVER, THERE WERE NO SIGNS OF DAMAGE WHERE THE CABLE BROKE OFF. THERE WERE SCUFF MARKS ON THE IDLER PULLEY WHERE THE CABLE WAS RESTING ON, BUT THE PULLEY MOVED FREELY. THE BLADES AND GRIPS DID NOT EXHIBIT DAMAGE. ENGINEERING EVALUATION ALSO FOUND THAT THE OTHER GRIP CABLE WAS DERAILED AT THE OPPOSITE DISTAL IDLER PULLEY OF THE BROKEN CABLE. THE CABLE SEEMED TO BE TENSIONED AS THE GRIPS STILL MOVED SIDE TO SIDE. NO OTHER DAMAGE WAS 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 DURING A DA VINCI S SURGICAL PROCEDURE, THE CABLE ON THE MEGASUTURECUT NEEDLE DRIVER INSTRUMENT BROKE AND THE GRIPS WOULD NOT OPEN AND CLOSE. NO MISSING OR FALLEN PIECES WERE 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
    74293 MEGASUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10120424 375

    Patients

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