BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3935377 · Received July 15, 2014

    Report

    Report Number
    2955842-2014-04282
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 18, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND A BROKEN PITCH CABLE AT THE PROXIMAL END. HOUSING WAS REMOVED AND FOUND A BROKEN PITCH CABLE AT THE CLAMPING PULLEY. OTHER BACKEND CABLES WERE NOT DAMAGED. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE FOLLOWING UNREPORTED DAMAGES: THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE NOT ALIGNED WITH THE TUBE AXIS. THE CLAMPING PULLEY EXHIBITED ORANGE COLORED RESIDUE. FAILURE ANALYSIS CONCLUDED THAT THE RESIDUE WAS LIKELY DUE TO MISHANDLING. NO OTHER DAMAGE WAS FOUND. THE REPROCESSING INSTRUCTIONS UNDER CLEANING, DISINFECTION, AND STERILIZATION GENERAL INFORMATION SECTION SPECIFICALLY STATES: WARNING: READ ALL INSTRUCTIONS CAREFULLY. FAILURE TO PROPERLY FOLLOW INSTRUCTIONS MAY CAUSE IMPROPER FUNCTIONING OF THE DEVICE. HANDLE WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE DEVICE. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE ADDITIONAL FINDING OF THE MAIN TUBE MATERIAL REMOVAL FOUND DURING FAILURE ANALYSIS COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN CENTRAL PROCESSING, THE CABLE WAS STARTING TO COME OUT OF THE SHAFT, VERY LOOSE ON A PROGRASP FORCEPS INSTRUMENT. THERE WAS NO ALLEGATION OF HARM OR INJURY TO A PATIENT. NOTHING REPORTEDLY FELL INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413310 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-11 N10140407 036

    Patients

    Seq Age Sex Outcome Treatment
    1