BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPSINSTRUMENT

    MDR report key: 3840011 · Received May 29, 2014

    Report

    Report Number
    2955842-2014-03325
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 2, 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 CONFIRMED THE REPORTED COMPLAINT. THE PITCH DOWN CABLE WAS FRAYED AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN THE CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. OTHER CABLES AT THE WRIST WERE NOT DAMAGED. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE FRAYED CABLE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI TRIFLAP PROCEDURE THAT WAS STARTED AROUND 2 P.M AND COMPLETED ABOUT 6 P.M. DURING THE PROCEDURE, A SURGEON SAID SECOND ARM MOVEMENT IS NOT GOOD. IT DOESN'T SEEM TO HAVE ANY ENERGY AND A NURSE CHECKED AND FOUND THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WIRE HAS BEEN BROKEN. BECAUSE THIS EVENT WAS OCCURRED AT THE END OF THE PROCEDURE, THE CUSTOMER COMPLETED IT WITHOUT CHANGING INSTRUMENT. THE SURGEON IS EXPERIENCED AND HE COMPLAINED WHY WIRES HAVE BEEN BROKEN TOO MUCH WHEN HE PERFORMS SURGERIES AND SAID THAT HE WILL SAY THIS ISSUE TO INTUITIVE SURGICAL DIRECTOR. NOTHING REPORTEDLY FELL INTO A PATIENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317008 FENESTRATED BIPOLAR FORCEPSINSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 M11131130 510

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR