BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3999846 · Received August 11, 2014

    Report

    Report Number
    2955842-2014-04873
    Event Type
    Malfunction
    Date Received
    August 11, 2014
    Date of Event
    May 13, 2014
    Report Date
    July 14, 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. THE CUSTOMER REPORTED COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE HOUSING WAS REMOVED TO FIND ONE PITCH CABLE DERAILED FROM THE BACK IDLER PULLEYS. THE CABLE WAS WEDGED BETWEEN TWO PULLEYS AND HAD LOST TENSION. THE CLAMPING PULLEY SCREWS ARE STILL TIGHT. NON-INTUITIVE MOTION OCCURS AS A RESULT. ADDITIONAL OBSERVATION DURING FAILURE ANALYSIS FOUND THE DISTAL END OF MAIN TUBE HAD VARIOUS SCRATCHES WITH LIGHT MATERIAL REMOVED. THE SCRATCHES WERE .012-.081 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER MAIN TUBE SCRATCHES IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS NOT RESPONDING ACCORDING TO MOVEMENT OF THE SURGEONS HANDS, DURING A DA VINCI HYSTERECTOMY PROCEDURE. THERE WERE NO MISSING OR FALLEN PIECES REPORTED. THERE WAS NO ALLEGATION OF ANY HARM, INJURY, OR ADVERSE OUTCOME TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476590 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 M10131203 101

    Patients

    Seq Age Sex Outcome Treatment
    1