BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 2912362 · Received January 11, 2013

    Report

    Report Number
    2955842-2013-00161
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 13, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K061260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. THE CUSTOMER INITIALLY REPORTED FRAYED WIRE, HOWEVER, FOR CLARIFICATION THE DAMAGED INSTRUMENT COMPONENT WAS A BROKEN PITCH CABLE. BASED ON THIS CLARIFICATION, THE CUSTOMER REPORTED COMPLAINT IS CONFIRMED. THE PITCH CABLE IS BROKEN AT THE DISTAL CLEVIS HUB. CABLE SEGMENT THAT CONTAINS THE CRIMP IS STILL INSTALLED IN CLEVIS. CLEVIS DOES NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. ELECTRICAL CONTINUITY PASSED. ADDITIONAL FINDING: SCRATCHES ON MAINTUBE. DISTAL END OF MAIN TUBE HAS VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. SCRATCHES ARE SHORT IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS, SUGGESTING THE MAY HAVE BEEN CAUSED BY INSTRUMENT COLLISIONS OR ROUGH HANDLING. 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 INTRAOPERATIVELY. THIS MAY RESULT IN DAMAGE TO THE INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI MYOMECTOMY PROCEDURE, THE SURGICAL STAFF REPORTED SEEING FRAYED WIRES ON THE PK DISSECTING FORCEPS INSTRUMENT. NOTHING WAS REPORTED HAVING FALLEN INTO THE PATIENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16410 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-03 M10121002 916

    Patients

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