BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOWEL GRASPER INSTRUMENT

    MDR report key: 3715462 · Received March 31, 2014

    Report

    Report Number
    2955842-2014-01877
    Event Type
    Malfunction
    Date Received
    March 31, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 5, 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 INSTRUMENTS MAIN TUBE HAD SCRATCH MARKS AND ABRASIONS. THE MAIN TUBE INSULATION WAS SCRATCHED AND SOME OF THE INSULATION HAD BEEN REMOVED AT THE DISTAL END. THE SCRATCHES MEASURED APPROXIMATELY .023 - .114 IN LENGTH. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT IN ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE SCRATCH MARK AND ABRASION DAMAGE TO THE MAIN TUBE 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 SURGICAL PROCEDURE, IT WAS NOTED THAT THE SHAFT ON THE BOWEL GRASPER INSTRUMENT WAS DAMAGED. THERE WAS NO REPORT OF ANY FRAGMENTS FALLING INTO A PATIENT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189214 BOWEL GRASPER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420177-04 S10130518 910

    Patients

    Seq Age Sex Outcome Treatment
    1