BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 2871139 · Received December 12, 2012

    Report

    Report Number
    2955842-2012-01277
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    August 21, 2012
    Report Date
    September 10, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K061260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. THE COMPLAINT THE INSTRUMENT WOULD NOT RESPOND TO THE SURGEON'S MOVEMENT IS CONFIRMED. INSTRUMENT PLACED ON IS3000 SYSTEM AND DRIVEN. RECOGNITION AND ENGAGEMENT PASSED. PITCH MOTION WAS NOT INTUITIVE, MOTION AT DISTAL END WAS JERKY AND DELAYED WITH RESPECT TO MOTION OF MASTERS. HOUSING WAS REMOVED TO FIND BOTH PITCH CABLES LOOSE AT THE BACKEND. CABLES HAVE LOST TENSION, BUT ARE NOT DERAILED. CLAMPING PULLEY SCREWS ARE TIGHT. ADDITIONAL OBSERVATIONS NOT REPORTED BY SITE ARE BENT GRIPS AND TUBE DAMAGE. ONE GRIP IS BENT, CAUSING SIDE TO SIDE MISALIGNMENT OF GRIPS. THERE IS A .030 OFFSET AT THE TIPS. BENT GRIP HAS SEPARATION OF THE YAW PULLEY AND PULLEY COVER AT THE GLUE JOINT, INDICATING OVERLOADING AT THE TIP. DISTAL END OF MAIN TUBE HAS VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. SCRATCHES ARE .120 - .160 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. EVIDENCE NOT CONCLUSIVE, BUT DAMAGE MAY HAVE BEEN CAUSED BY MISHANDLING/MISUSE. NO OTHER DAMAGE 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. 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 DURING A HYSTERECTOMY DA VINCI SI PROCEDURE THE PK DISSECTING FORCEPS INSTRUMENT WOULD NOT RESPOND TO THE SURGEON'S MOVEMENT. 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
    1 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-03 M10101006 528

    Patients

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