BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3893775 · Received June 25, 2014

    Report

    Report Number
    2955842-2014-03880
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 6, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS FOUND THE INSTRUMENT'S BIPOLAR INSERT TO BE DISLODGED. THE BIPOLAR PINS WERE OBSERVED TO BE STICKING OUT AT THE CHASSIS. SOME BIPOLAR CORDS WERE A TIGHT FIT ON THE BIPOLAR PINS MAY REQUIRE A HIGH REMOVAL FORCE, POTENTIALLY CAUSING THE INSERT TO PULL OUT. FAILURE ANALYSIS INVESTIGATION ALSO FOUND INSULATION DAMAGE ON THE DISTAL END OF THE MAIN TUBE. MATERIAL WAS OBSERVED TO BE MISSING. THE SURFACE OF THE MAIN TUBE APPEARED TO BE SCRAPED OFF IN VARIOUS AREAS. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT IN ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE INSULATION DAMAGE WITH MATERIAL MISSING FOUND DURING FAILURE ANALYSIS IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI NEPHRECTOMY SURGICAL PROCEDURE, THE BIPOLAR CONNECTION WAS IDENTIFIED TO BE OUT OF THE MARYLAND BIPOLAR FORCEPS INSTRUMENT. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371319 MARYLAND BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-09 N11140324 154

    Patients

    Seq Age Sex Outcome Treatment
    1