BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 4003164 · Received August 12, 2014

    Report

    Report Number
    2955842-2014-04896
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 16, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. THE CUSTOMER REPORTED COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE INSTRUMENT PITCH CABLE WAS FRAYED AT THE PROXIMAL CLEVIS HUB. THE CLEVIS DID NOT EXHIBIT ANY WEAR. THE FRAYED STRANDS STUCK OUT AT THE WRIST. OTHER CABLES AT THE WRIST WERE NOT DAMAGED. AN ADDITIONAL FINDING BY FAILURE ANALYSIS FOUND THE INSTRUMENT MAIN TUBE HAD SCRATCH MARKS/ ABRASIONS. THE DISTAL END OF MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVED. THE SCRATCHES WERE NOT ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER THE FRAYED PITCH CABLE AND/OR MAIN TUBE SCRATCHES IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS OBSERVED DURING CENTRAL PROCESSING, THE CABLE WAS DAMAGED ON THE FENESTRATED BIPOLAR FORCEPS. THERE WERE NO MISSING OR FALLEN PIECES REPORTED. THERE WAS NO ALLEGATION OF ANY HARM, INJURY, OR ADVERSE OUTCOME TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478781 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 M10140131 690

    Patients

    Seq Age Sex Outcome Treatment
    1