BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL GRASPING RETRACTOR INSTRUMENT

    MDR report key: 2853524 · Received December 3, 2012

    Report

    Report Number
    2955842-2012-01144
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 2, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE PITCH CABLE WAS BROKEN AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN THE CLEVIS. THE CLEVIS DOES NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. 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 DURING REPROCESSING OF THE SMALL GRASPING RETRACTOR INSTRUMENT, THE WIRE ON THE INSTRUMENT WAS OBSERVED TO BE BROKEN. THERE WERE NO MISSING OR FALLEN PIECES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMALL GRASPING RETRACTOR INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420318-02 M10120528 336

    Patients

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