BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3882058 · Received June 18, 2014

    Report

    Report Number
    2955842-2014-03748
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 20, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS CONFIRMED THE REPORTED COMPLAINT. THE PITCH DOWN CABLE WAS FRAYED AT THE DISTAL CLEVIS HUB. SMALL FRAYED STRANDS STUCK OUT AT THE WRIST. OTHER CABLES AT THE WRIST WERE NOT DAMAGED. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE FOLLOWING DAMAGES TO THE INSTRUMENT: ONE GRIP OPEN CABLE ON ONE SIDE OF DISTAL CLEVIS WAS DERAILED FROM DISTAL IDLER PULLEYS. YAW MOTION WAS NON-INTUITIVE AS A RESULT. AN ADDITIONAL FINDING WAS VARIOUS SCRATCHES ON THE DISTAL END OF THE MAIN TUBE SHOWING LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE .143 - .216 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 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 DURING A DA VINCI HYSTERECTOMY PROCEDURE, THE PROGRASP FORCEPS INSTRUMENT WAS BROKEN. NOTHING REPORTEDLY FELL INTO A PATIENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. ON (B)(4) 2014, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE INITIAL REPORTER AT THE HOSPITAL AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. IT WAS REPORTED THE DAMAGE WAS, WIRES WERE STICKING OUT OF THE INSTRUMENT AND THE JAWS WOULD NOT LINE UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358972 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-10 M11131123 880

    Patients

    Seq Age Sex Outcome Treatment
    1