BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOWEL GRASPER

    MDR report key: 2935834 · Received January 30, 2013

    Report

    Report Number
    2955842-2013-00316
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    December 10, 2012
    Report Date
    January 4, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DAVINCI SI COLECTOMY PROCEDURE, THE CUSTOMER NOTED LOSS OF INSULATION, MANIPULATION OF TIP ON THE BOWEL GRASPER INSTRUMENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41387 BOWEL GRASPER ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420177 S10121108 591

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES