BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY SPATULA INSTRUMENT

    MDR report key: 2914403 · Received January 14, 2013

    Report

    Report Number
    2955842-2013-00172
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE PITCH CABLE IS BROKEN AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT THAT CONTAINS THE CRIMP IS STILL REMAINED IN THE CLEVIS. THE CLEVIS DOES NOT EXHIBIT EXCESSIVE DAMAGE. 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 SUCCESSFUL COMPLETION OF A DA VINCI SI SALPINGECTOMY PROCEDURE THE WIRE AT THE TIP OF THE PERMANENT CAUTERY HOOK INSTRUMENT WAS STICKING OUT. THERE WERE NO MISSING OR FALLEN PIECES REPORTED. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20682 PERMANENT CAUTERY SPATULA INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420184-06 M10111206 305

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR DA VINCI SI SURG. SYSTEM, ACCESSORIES AND ESU.