BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADIERE FORCEPS INSTRUMENT

    MDR report key: 3961088 · Received July 28, 2014

    Report

    Report Number
    2955842-2014-04559
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 17, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION FOUND THE INSTRUMENT'S GRIP CABLES WERE DERAILED. ONE GRIP CABLE WAS DERAILED AT THE DISTAL IDLER PULLEY. THE GRIPS STILL OPENED AND CLOSED, BUT MOVEMENT WAS NOT PRECISE. FAILURE ANALYSIS ALSO FOUND THE FOLLOWING: THE INSTRUMENT'S GRIP CABLE WAS FRAYED. THE SAME GRIP CABLE THAT WAS DERAILED WAS ALSO FRAYED; THE DISTAL IDLERS DID NOT APPEAR TO HAVE ANY DAMAGE. THE INSTRUMENT'S MAIN TUBE HAD SCRATCH MARKS AND ABRASIONS. THE DISTAL END OF MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE NOT ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT IN ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE FRAYED CABLE AND DAMAGE TO THE MAIN TUBE IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN CENTRAL PROCESSING THAT THE WIRE AT THE END OF THE CADIERE FORCEPS INSTRUMENT WAS OFF TRACK. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO THE PATIENT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439617 CADIERE FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420049-08 M10131122 579

    Patients

    Seq Age Sex Outcome Treatment
    1