BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3920339 · Received July 8, 2014

    Report

    Report Number
    2955842-2014-04161
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 10, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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 CLEVIS HUB. THE CLEVIS DID NOT EXHIBIT ANY WEAR. THE BROKEN STRANDS STUCK OUT AT THE INSTRUMENT'S WRIST. OTHER CABLES AT THE WRIST 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. INSTRUMENT GRIP HAD INDENTATIONS AT THE EDGES. FAILURE ANALYSIS CONCLUDED THAT THE INDENTATIONS WERE LIKELY DUE TO MISHANDLING. NO OTHER DAMAGE WAS FOUND. THE ENDOWRIST® INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE BROKEN CABLE AND THE ADDITIONAL FINDING OF THE MAIN TUBE MATERIAL REMOVAL FOUND DURING FAILURE ANALYSIS COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF THE MALFUNCTIONS WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN CENTRAL PROCESSING, THE PROGRASP FORCEPS INSTRUMENT WAS OBSERVED TO HAVE A CABLE STICKING OUT. 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
    397976 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M10130920 269

    Patients

    Seq Age Sex Outcome Treatment
    1