BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS

    MDR report key: 2895839 · Received January 3, 2013

    Report

    Report Number
    2955842-2013-00050
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    November 28, 2012
    Report Date
    December 6, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING OBSERVED THAT THE GRIP, TIP AND TEETH ARE PERFECTLY IN POSITION. HOWEVER, FINDINGS REVEALED A BROKEN PITCH CABLE AND SCRATCHES ON THE MAIN TUBE. THE DISTAL END OF THE MAIN TUBE HAS VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL, SUGGESTING IT MAY HAVE BEEN CAUSED BY INSTRUMENT COLLISIONS OR ROUGH HANDLING. THE PITCH CABLE IS BROKEN AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT THAT CONTAINS THE CRIMP IS STILL INSTALLED IN CLEVIS. THE CLEVIS DOES NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. ELECTRICAL CONTINUITY PASSED. THE INSTRUMENT HAS 2 USES REMAINING. 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. DO NOT USE AN INSTRUMENT TO CLEAN DEBRIS FROM ANOTHER INSTRUMENT INTRAOPERATIVE. THIS MAY RESULT IN DAMAGE TO THE INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP. PER THE CUSTOMER, AT THE TIME OF THE REPORTED EVENT, NOTHING FELL INTO A PATIENT DURING A SURGICAL PROCEDURE. 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 NOTICED THAT PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE, THE TIP OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS BENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3314 FENESTRATED BIPOLAR FORCEPS ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 M10110909 922

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES