BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL GRASPING RETRACTOR, 8MMINSTRUMENT

    MDR report key: 2991338 · Received March 6, 2013

    Report

    Report Number
    2955842-2013-00741
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT ENGINEERING EVALUATION FOUND THAT THE OF INSTRUMENT WITH WIRES EXPOSED WAS CONFIRMED. INSTRUMENT WAS FOUND WITH FRAYED PITCH CABLE AT THE DISTAL CLEVIS HUB. NO DAMAGE WAS FOUND AT THE CLEVIS. THE FRAYED SEGMENT WAS APPROXIMATELY 0.04 IN LENGTH. THERE WAS NO OTHER CABLE DAMAGE FOUND. 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 PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE THE 8MM SMALL GRASPING RETRACTOR INSTRUMENT WAS NOTED TO HAVE EXPOSED WIRES. NO MISSING OR FALLEN PIECES WERE REPORTED. 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
    96201 SMALL GRASPING RETRACTOR, 8MMINSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420318-02 M10121023 953

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR DA VINCI SI SYSTEM, INSTRUMENTS AND ACCESSORIES