BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3914867 · Received July 4, 2014

    Report

    Report Number
    2955842-2014-04107
    Event Type
    Malfunction
    Date Received
    July 4, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 13, 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. FAILURE ANALYSIS INVESTIGATION FOUND THAT THE PITCH UP CABLE WAS BROKEN AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN THE CLEVIS. NO OTHER DAMAGE OR WEAR MARKS WERE OBSERVED ON THE CLEVIS. THE OTHER CABLES AT THE WRIST WERE UNDAMAGED. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE BROKEN CABLE FOUND DURING FAILURE ANALYSIS INVESTIGATION, 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 THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT TIP WAS BROKEN - IT WOULD NOT OPEN. THE INSTRUMENT WAS NOT USED ON A PATIENT. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT, AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392817 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-07 N10140424 921

    Patients

    Seq Age Sex Outcome Treatment
    1