BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY SPATULA INSTRUMENT

    MDR report key: 2001957 · Received February 27, 2011

    Report

    Report Number
    2955842-2011-00057
    Event Type
    Malfunction
    Date Received
    February 27, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 26, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K002489
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT ENGINEERING FOUND THE INSTRUMENT RETURNED WITH A PIECE OF THE DISTAL CLEVIS BROKEN. ONE DISTAL CLEVIS EAR IS BROKEN OFF AT ITS BASE. THE BROKEN PIECE WAS NOT RETURNED; HOWEVER, THE MISSING PIECE WAS ROUGHLY .300 X .235 AND WAS LOCATED ON THE OPPOSITE SIDE OF THE CONDUCTOR WIRE AND CAP. ENGINEERING HAS CONCLUDED THAT THE INSTRUMENT BREAKAGE MAY BE DUE TO OVERLOADING THE TIP. NO OTHER DAMAGE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, A BROWN PIECE FROM THE DISTAL END OF THE PERMANENT CAUTERY SPATULA HAD FALLEN INTO THE PATIENT. THE PIECE WAS SUCCESSFULLY RETRIEVED AND THE PROCEDURE COMPLETED WITH NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMANENT CAUTERY SPATULA INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420184-05 M10100823 925

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI S SYSTEM, INSTRUMENTS, ACCESSORIES, & ES