BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3971666 · Received July 31, 2014

    Report

    Report Number
    2955842-2014-04647
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    June 17, 2014
    Report Date
    July 23, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS FOUND THE INSTRUMENT'S PITCH UP CABLE TO BE FRAYED AT THE DISTAL CLEVIS HUB. THE DRIVE CABLE WAS ALSO FRAYED. FRAYED STRANDS WERE OBSERVED TO BE STICKING OUT AT THE WRIST OF THE INSTRUMENT. IN ADDITION, THE INSTRUMENT'S PITCH DOWN CABLE WAS BROKEN AT THE DISTAL CLEVIS HUB. THE BROKEN CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN THE CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE INSTRUMENT'S GRIP CABLE TO BE DERAILED FROM THE DISTAL IDLER PULLEY. THE GRIPS WERE STILL ABLE TO OPEN AND CLOSE, HOWEVER MOVEMENT MAY NOT BE PRECISE. THE DISTAL END OF THE INSTRUMENT'S MAIN TUBE HAD VARIOUS SCRATCH MARKS/ABRASIONS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES MEASURED APPROXIMATELY 0.069 - 0.349 IN LENGTH AND 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 THE ADDITIONAL FINDING OF VARIOUS SCRATCH MARKS ON THE MAIN TUBE WITH LIGHT MATERIAL REMOVAL FOUND DURING FAILURE ANALYSIS 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 HYSTERECTOMY SURGICAL PROCEDURE, A FRAYED WIRE WAS IDENTIFIED ON THE PROGRASP FORCEPS INSTRUMENT. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447620 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-11 M10140314 832

    Patients

    Seq Age Sex Outcome Treatment
    1