BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENACULUM FORCEPS INSTRUMENT

    MDR report key: 3173743 · Received June 17, 2013

    Report

    Report Number
    2955842-2013-02194
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 23, 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 THERE WAS A BROKEN PITCH CABLE AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENTS THAT CONTAINS THE CRIMP WAS MISSING FROM THE CLEVIS. THE CLEVIS DID NOT EXHIBIT EXCESSIVE DAMAGE. AN ADDITIONAL OBSERVATION NOT REPORTED BY THE CUSTOMER WAS MAIN TUBE DAMAGE. ENGINEERING FOUND SCRATCHES THROUGHOUT THE MAIN TUBE. EVIDENCE NOT CONCLUSIVE, BUT MAIN TUBE SCRATCHES ARE LIKELY 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 AND MAIN TUBE SCRATCHES IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE SURGEON IDENTIFIED A BROKEN CABLE ON THE TENACULUM FORCEPS INSTRUMENT. 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
    274311 TENACULUM FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420207-06 M10121008 869

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES