BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3920243 · Received July 8, 2014

    Report

    Report Number
    2955842-2014-04155
    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
    TX
    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 BROKEN AT THE PROXIMAL CLEVIS HUB. THE CLEVIS DID NOT EXHIBIT ANY WEAR. THE BROKEN STRANDS STUCK OUT AT THE WRIST. OTHER CABLES AT WRIST WERE NOT DAMAGED. ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS THE INSTRUMENT MAIN TUBE HAD SCRATCH MARKS/ABRASIONS. THE DISTAL END OF MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES ARE NOT ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGE FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER THE BROKEN CABLE AND MAIN TUBE SCRATCHES WERE TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAD A BROKEN WIRE. 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
    397799 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-07 N10140421 137

    Patients

    Seq Age Sex Outcome Treatment
    1