BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOWEL GRASPER INSTRUMENT

    MDR report key: 3812384 · Received May 15, 2014

    Report

    Report Number
    2955842-2014-03011
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION FOUND THE INSTRUMENT'S MAIN TUBE HAD SCRATCH MARKS AND ABRASIONS. THE MAIN TUBE INSULATION WAS SCRATCHED AND SOME OF THE INSULATION HAD BEEN REMOVED. THE SCRATCHES MEASURED APPROXIMATELY .031 - .116 IN LENGTH. THE DAMAGE IS LOCATED APPROXIMATELY 4.323 FROM THE DISTAL END OF THE MAIN TUBE. NO OTHER DAMAGE FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT IN ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE DAMAGE TO THE MAIN TUBE'S INSULATION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN CENTRAL PROCESSING, IT WAS NOTED THAT THERE WERE HOLES ON THE INSULATION OF THE SHAFT OF THE BOWEL GRASPER INSTRUMENT. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO THE PATIENT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291983 BOWEL GRASPER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420177-05 S10140319 404

    Patients

    Seq Age Sex Outcome Treatment
    1