BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LONG TIP FORCEPS INSTRUMENT

    MDR report key: 3171052 · Received June 14, 2013

    Report

    Report Number
    2955842-2013-02175
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 21, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. RECEIVED THE INSTRUMENT INVOLVED WITH THE COMPLAINT. ENGINEERING CONFIRMED THE INSTRUMENT WAS BROKEN AT THE PROXIMAL CLEVIS SIDE WITH CRACKED MAIN TUBE. CLEVIS WAS DISLODGED FROM MAIN TUBE AS A RESULT. THERE WERE NO MISSING PIECES. NO OTHER DAMAGE FOUND. ENGINEERING CONCLUDED THAT THE CRACKED MAIN TUBE LIKELY MAY BE DUE TO MISHANDLING. 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 REPORTED MALFUNCTION 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 SI SURGICAL PROCEDURE, THE SILVER TIP WAS PULLED OUT OF THE LONG TIP FORCEPS INSTRUMENT'S SHAFT. NO MISSING OR FALLEN PIECES WERE REPORTED. THE INSTRUMENT WAS NOT USED ON A PATIENT AFTER THE REPORTED ISSUE WAS IDENTIFIED. 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
    270598 LONG TIP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420048-06 M10130121 756

    Patients

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