BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3760206 · Received April 18, 2014

    Report

    Report Number
    2955842-2014-02381
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    March 10, 2014
    Report Date
    March 27, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THAT THE INSTRUMENT'S PITCH CABLE AT THE DISTAL CLEVIS WAS FRAYED AND HAD MINOR LOOSE TENSION. THERE WAS NO DAMAGE TO THE CABLES INSIDE OF THE HOUSING. THERE WAS NO DAMAGE AT THE CLEVIS. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE FOLLOWING ADDITIONAL DAMAGES TO THE INSTRUMENT: THE INSTRUMENT'S GRIP CABLE WAS FRAYED AT THE DISTAL IDLER. PULLEY. THE FRAYED STRANDS WERE STICKING OUT AT THE WRIST. THE EDGE OF THE INSTRUMENT'S DISTAL PULLEY EXHIBITED AN INDENTATION. THE SURFACE OF THE PULLEY ALSO HAD SCRATCHES. IT WAS CONCLUDED THAT THE DAMAGE TO THE PULLEY WAS LIKELY DUE TO MISHANDLING/MISUSE. THE DISTAL END OF THE INSTRUMENT'S MAIN TUBE HAD VARIOUS SCRATCH MARKS EXHIBITING LIGHT MATERIAL REMOVAL AND A ROUGH SURFACE FINISH. THE SCRATCHES WERE SHORT IN LENGTH AND WERE NOT AXIALLY ALIGNED WITH THE TUBE. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT IN ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE DAMAGE TO THE INSTRUMENT'S PITCH AND GRIP CABLES, AND MAIN TUBE, FOUND DURING FAILURE ANALYSIS INVESTIGATION 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 WIRES ON THE PROGRASP FORCEPS INSTRUMENT FRAYED. THERE WAS NO REPORT OF ANY FRAGMENT(S) FROM THE INSTRUMENT FELL INTO THE PATIENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237430 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-10 M10131028 620

    Patients

    Seq Age Sex Outcome Treatment
    1