BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 3112988 · Received May 15, 2013

    Report

    Report Number
    2955842-2013-01667
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    February 1, 2013
    Report Date
    April 18, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K061260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING CONFIRMED THE INSTRUMENT DOES NOT OPEN/CLOSE. ONE GRIP CLOSE CABLE WAS BROKEN AT THE DISTAL IDLERS. THE IDLER PULLEY SPUN FREELY AND DID NOT EXHIBIT DAMAGE. THE CABLE SEGMENT STUCK OUT AT THE INSTRUMENTS WRIST. OTHER CABLES AT THE WRIST WERE NOT DAMAGED. ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS A BROKEN CONDUCTOR WIRE. ONE CONDUCTOR WIRE WAS BROKEN AT THE YAW PULLEY EXIT. THE WIRE STUCK OUT FROM THE YAW PULLEY. NO CHAR MARKS WERE OBSERVED ON THE YAW PULLEY. ELECTRICAL CONTINUITY TEST FAILED. 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 DURING A DA VINCI SURGICAL PROCEDURE THE PK DISSECTING FORCEPS INSTRUMENT CAN NOT OPEN ANYMORE. THERE WERE NO MISSING PIECES OR FALLEN PIECES REPORTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214620 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 400227-02 M10120522 238

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SYSTEM INSTRUMENTS & ACCESSORIES ESU