BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 3143589 · Received June 3, 2013

    Report

    Report Number
    2955842-2013-01963
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 9, 2013
    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. ENGINEERING WAS UNABLE TO CONFIRM THE REPORTED FAILURE MODE. THE INSTRUMENT WAS PLACED ON IN-HOUSE DA VINCI ROBOT SYSTEM, AND THE SYSTEM SUCCESSFULLY RECOGNIZED THE INSTRUMENT. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTS. ADDITIONAL OBSERVATIONS NOT REPORTED BY SITE WERE BENT TIPS, DISTAL PULLEY DAMAGE AND MAIN TUBE DAMAGE. FIRST FINDING, ONE GRIP WAS FOUND TO BE BENT, CAUSING SIDE TO SIDE MISALIGNMENT OF GRIPS. THERE WAS A 0.088¿ OFFSET AT THE TIPS, INDICATING OVERLOADING AT THE TIP. SECOND FINDING, SCRATCHES ON THE SURFACE OF THE DISTAL PULLEY. THIRD FINDING, THE DISTAL END OF THE MAIN TUBE EXHIBITED VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL AND A ROUGH SURFACE FINISH. THE SCRATCHES WERE SHORT IN LENGTH AND WERE NOT ALIGNED WITH THE TUBE AXIS. ENGINEERING CONCLUDED THAT DAMAGES WERE LIKELY DUE TO MISHANDLING. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS - HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION OF SCRATCHES ON THE MAIN TUBE IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI S SURGICAL PROCEDURE, THE PK DISSECTING FORCEPS INSTRUMENT WAS NOT BEING RECOGNIZED BY THE DA VINCI ROBOT SYSTEM. INSTRUMENT WAS NOT USED IN THE CASE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244582 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-03 M10120425 111

    Patients

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