BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3971568 · Received July 31, 2014

    Report

    Report Number
    2955842-2014-04643
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THE PITCH UP CABLE IS FRAYED AT THE DISTAL CLEVIS HUB. THE FRAYED STRANDS STICK OUT AT THE WRIST. THE OTHER CABLES AT THE WRIST ARE NOT DAMAGED. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THAT THE DISTAL END OF THE INSTRUMENT'S MAIN TUBE HAS VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES ARE .023 - .154 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; THE FRAYED CABLE, AND THE ADDITIONAL FINDING OF TUBE ABRASIONS WITH MATERIAL REMOVED, FOUND DURING FAILURE ANALYSIS EVALUATION COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CABLE ON THE PROGRASP FORCEPS INSTRUMENT WAS FRAYED. THERE WAS NO ALLEGATION THAT ANY PIECE(S) FROM THE INSTRUMENT FELL INTO A PATIENT AND THERE WAS NO REPORT THAT THERE WAS ANY PATIENT HARM OR ADVERSE OUTCOME INVOLVING THE REPORTED INSTRUMENT. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448295 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-10 M10131119 041

    Patients

    Seq Age Sex Outcome Treatment
    1