BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3232509 · Received July 18, 2013

    Report

    Report Number
    2955842-2013-02586
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 20, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED ON (B)(4) 2013. ENGINEERING NOTED BENT GRIPS AND MAIN TUBE DAMAGE WITH THE RETURNED INSTRUMENT. ONE GRIP WAS BENT, WHICH CAUSES SIDE TO SIDE MISALIGNMENT OF GRIPS. THERE WAS A 0.150 OFFSET AT THE TIPS. THE BENT GRIP HAD SEPARATION OF THE YAW PULLEY AND PULLEY COVER AT THE GLUE JOINT, INDICATING OVERLOADING AT THE TIP. THE DISTAL END OF MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. SCRATCHES WERE 0.080 - 0.145 IN LENGTH AND WERE NOT ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGE WAS FOUND. EVIDENCE NOT CONCLUSIVE, BUT MAIN TUBE DAMAGE MAY HAVE BEEN CAUSED BY MISHANDLING/MISUSE. THE INSTRUMENTS & ACCESSORIES 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 MAIN TUBE DAMAGE FOUND DURING FAILURE ANALYSIS COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF TO REOCCUR.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED INTUITIVE SURGICAL, INC. ABOUT THE PRECISE BIPOLAR FORCEPS INSTRUMENT BUT NO DESCRIPTION OF THE INSTRUMENT WAS PROVIDED. NOTHING REPORTEDLY FELL INTO A PATIENT. 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
    336049 PRECISE BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420110-06 M10121016 813

    Patients

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