BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3938619 · Received July 16, 2014

    Report

    Report Number
    2955842-2014-04327
    Event Type
    Malfunction
    Date Received
    July 16, 2014
    Date of Event
    June 25, 2014
    Report Date
    July 10, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS FOUND THE INSTRUMENT'S BIPOLAR PINS TO BE BENT. THE BOTTOM BIPOLAR PIN WAS BENT UPWARD TOWARD THE TOP BIPOLAR PIN. FAILURE ANALYSIS CONCLUDED THAT THE BENT DAMAGE MAY BE DUE TO MISHANDLING/MISUSE. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE INSTRUMENT'S PITCH CABLE TO BE LOOSE. THE PITCH UP CABLE WAS STARTING TO UNRAVEL. THE OTHER CABLE AT THE WRIST OF THE INSTRUMENT DID NOT APPEAR TO BE DAMAGED. IN ADDITION, THE INSTRUMENT'S MAIN TUBE HAD SCRATCH MARKS/ABRASIONS. THE DISTAL END OF THE 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 INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. THE CUSTOMER REPORTED COMPLAINT DOES NOT IN ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE VARIOUS SCRATCH MARKS ON THE MAIN TUBE WITH LIGHT MATERIAL REMOVAL 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 PROSTATECTOMY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE PRONGS ON TOP OF THE PRECISE BIPOLAR FORCEPS INSTRUMENT WERE BROKEN. 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
    415306 PRECISE BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420110-06 M10131115 996

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR