BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3922092 · Received July 9, 2014

    Report

    Report Number
    2955842-2014-04181
    Event Type
    Malfunction
    Date Received
    July 9, 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. FAILURE ANALYSIS INVESTIGATION WAS UNABLE TO CONFIRM THE CUSTOMER REPORTED FAILURE MODE. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE DA VINCI SYSTEM AND IT PASSED RECOGNITION AND ENGAGEMENT TESTING. AN ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS THAT THE INSTRUMENT'S MAIN TUBE EXHIBITED SCRATCH MARKS/ABRASIONS. THE DISTAL END OF MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. 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 DAMAGE TO THE INSTRUMENT'S MAIN TUBE FOUND DURING FAILURE ANALYSIS INVESTIGATION COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SURGICAL PROCEDURE, THE CUSTOMER NOTED THAT THE ROBOT NEVER REGISTERED THE MARYLAND BIPOLAR FORCEPS INSTRUMENT. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401137 MARYLAND BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-07 M10121024 201

    Patients

    Seq Age Sex Outcome Treatment
    1