BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENACULUM FORCEPS INSTRUMENT

    MDR report key: 2931915 · Received January 28, 2013

    Report

    Report Number
    2955842-2013-00306
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 8, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THE CUSTOMER REPORTED FAILURE MODE; HOWEVER, FOR CLARIFICATION, THE DAMAGED INSTRUMENT COMPONENT WAS A BROKEN GRIP CABLE. THE GRIP CABLE AT THE DISTAL IDLER PULLEY IS BROKEN. THE IDLER PULLEY WAS OBSERVED TO SPIN FREELY AND CABLE SEGMENTS WERE FOUND TO BE STICKING OUT AT THE WRIST. ENGINEERING EVALUATION ALSO FOUND THAT THE DISTAL END OF THE MAIN TUBE EXHIBITS INSULATION DAMAGE. MATERIAL WAS FOUND TO BE MISSING. THE SURFACE OF THE MAIN TUBE APPEARED TO BE SCRAPED OFF. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI SI GYNECOLOGICAL SURGICAL PROCEDURE, IT WAS OBSERVED THAT WIRES ON THE TENACULUM FORCEPS INSTRUMENT WERE STICKING OUT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37871 TENACULUM FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420207-06 M10121008 806

    Patients

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