BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3935491 · Received July 15, 2014

    Report

    Report Number
    2955842-2014-04288
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 19, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION WAS NOT ABLE TO VERIFY THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS PUT ON AN IN-HOUSE SYSTEM AND THE GRIPS OPENED AND CLOSED WITHOUT ANY ISSUES. FAILURE ANALYSIS INVESTIGATION ALSO FOUND A BROKEN PITCH CABLE AT THE PROXIMAL CLEVIS HUB. THE CLEVIS DID NOT EXHIBIT ANY WEAR. THE BROKEN STRANDS STUCK OUT AT THE INSTRUMENT'S WRIST. OTHER CABLES AT THE WRIST WERE NOT DAMAGED. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE BROKEN CABLE FOUND DURING FAILURE ANALYSIS COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SURGICAL PROCEDURE, THE TIPS WILL NOT OPEN AND CLOSE PROPERLY. THE INSTRUMENT WAS NOT USED ON THE PATIENT AFTER THE REPORTED ISSUE WAS IDENTIFIED AND THERE WAS NO ALLEGATION OF HARM OR INJURY TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414274 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 M10131218 351

    Patients

    Seq Age Sex Outcome Treatment
    1