BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 1831273 · Received September 10, 2010

    Report

    Report Number
    2955842-2010-00394
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 9, 2010
    Report Date
    August 16, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K013416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION, HOWEVER, AN ISI FIELD ENGINEER ONSITE EVALUATED THE INSTRUMENT AND FOUND THE INSTRUMENT TO BE FULLY FUNCTIONAL WITH NO PHYSICAL DAMAGE. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S GYNECOLOGICAL PROCEDURE A PIECE OF WIRE WAS FOUND IN THE PATIENT. THE WIRE WAS IMMEDIATELY REMOVED AND THE PROGRASP FORCEPS INSTRUMENT THAT WAS IN USE AT THE TIME WAS ALSO REMOVED FOR INSPECTION. THE SURGICAL STAFF EVALUATED THE INSTRUMENT HOWEVER THEY DID NOT SEE ANY DAMAGE AND NOTED THAT THERE WAS NO SYSTEM ISSUES DURING THE PROCEDURE. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATION, INJURY OR ADVERSE OUTCOME WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M10100408 686

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI S SYS, INSTRUMENTS AND ACCESSORIES