BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3041566 · Received April 8, 2013

    Report

    Report Number
    2955842-2013-01154
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING EVALUATION FOUND THAT THE WIRE IS VISIBLE IN THE END OF THE INSTRUMENT. BOTH OF THE PITCH CABLES WERE BROKEN AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENTS THAT CONTAINED THE CRIMP WERE STILL INSTALLED IN THE CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. THE OTHER CABLES AT THE WRIST WERE NOT DAMAGED. ENGINEERING ALSO FOUND A POGO PIN THAT WAS STUCK. THE INSTRUMENT COULD NOT BE READ ON AN IN-HOUSE SYSTEM OR DCP (DALLAS CHIP PROGRAMMER) DUE TO ONE THE POGO PIN WAS STUCK IN THE DOWN POSITION. THE POGO PIN DID NOT POP UP WHEN MANUALLY ACTUATED. IT APPEARED THAT SOMETHING WAS WEDGED BETWEEN THE PIN AND THE BARREL. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS NOTED TO HAVE A WIRE VISIBLE AT THE END OF THE INSTRUMENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144075 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 M10120926

    Patients

    Seq Age Sex Outcome Treatment
    1 DAVINCI SI SYSTEM, ESU, INSTRUMENTS & ACCESSORIES