BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3790833 · Received May 5, 2014

    Report

    Report Number
    2955842-2014-02772
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 7, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THAT THE GRIP CABLE WAS FRAYED AT THE DISTAL IDLER PULLEY. THE FRAYED STRANDS STUCK OUT AT THE WRIST. THE OTHER CABLES AT THE WRIST WERE NOT DAMAGED. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE FOLLOWING ADDITIONAL DAMAGES TO THE INSTRUMENT: THE GRIP CLOSE CABLE WAS DERAILED AT THE DISTAL IDLER PULLEY. THE GRIPS COULD STILL OPEN AND CLOSE, BUT MOVEMENT MAY NOT BE PRECISE. THE CABLE DERAILMENT WAS LIKELY DUE TO THE CABLE LOSING CONTACT WITH THE PULLEY DURING WRIST ARTICULATION. THE FLEET ANGLE BETWEEN THE PROXIMAL AND DISTAL PULLEYS MAY HAVE CONTRIBUTED TO THE DERAILMENT. THERE WAS AN INDENTATION AT THE EDGE OF THE INSTRUMENT'S DISTAL PULLEY AND VISIBLE SCRATCHES ON THE SURFACE OF THE PULLEY. IT WAS CONCLUDED THAT THE INDENTATION DAMAGE FOUND TO THE DISTAL PULLEY WAS LIKELY DUE TO MISHANDLING/MISUSE. 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 DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS EXHIBITING LIGHT MATERIAL REMOVAL AND A ROUGH SURFACE FINISH. THE SCRATCHES WERE SHORT IN LENGTH AND NOT AXIALLY ALIGNED WITH THE TUBE. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE FRAYED CABLE AND/OR TUBE ABRASIONS WITH MATERIAL REMOVED 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 DURING THE REPROCESSING OF A DA VINCI PROGRASP FORCEPS INSTRUMENT, AFTER CLEANING, A SMALL WIRE WAS IDENTIFIED AS BEING BROKEN AND STICKING OUT AT THE END. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT, AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266337 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-10 M11140113 305

    Patients

    Seq Age Sex Outcome Treatment
    1