BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 1061801 · Received June 13, 2008

    Report

    Report Number
    2955842-2008-01075
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Report Date
    June 13, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING FOUND ONE GRIP TO BE SEVERELY BENT, CAUSING SIDE TO SIDE MISALIGNMENT OF GRIPS. THERE IS A .200" OFFSET AT THE TIPS. THE BENT GRIP HAS SEPARATION OF THE YAW PULLEY AND CONDUCTOR CAP AT THE GLUE JOINT, INDICATING OVERLOADING AT THE TIP. THE SEVERITY OF THE BEND SUGGESTS SOME KIND OF MISHANDLING/MISUSE HAD OCCURRED. THE DISTAL END OF THE MAIN TUBE HAS MATERIAL REMOVED IN THE FORM OF A COMBINATION OF DEEP SCRATCHES SUPERIMPOSED OVER A SCRAPE MARK. THE SCRAPING MAY HAVE BEEN CAUSED BY CLEANING/HANDLING. SCRATCHES ARE LIKELY FROM AN INSTRUMENT COLLISION. 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. 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 A PK DISSECTING FORCEPS INSTRUMENT DID NOT WORK. NO ADDITIONAL INFORMATION WAS PROVIDED. 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 ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL, INC. 420227-02 0801181 547

    Patients

    Seq Age Sex Outcome Treatment
    1 AN ELECTROSURGICAL UNIT| DA VINCI S SURGICAL SYSTEM| ACCESSORIES