BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORACIC GRASPER INSTRUMENT

    MDR report key: 3011583 · Received March 19, 2013

    Report

    Report Number
    2955842-2013-00901
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING EVALUATION RESULTS CONFIRMED THE ALLEGED ISSUE OF A TORN BLACK HOUSING. THE INSULATION COATING OF THE INSTRUMENT'S MAIN TUBE WAS FOUND TO BE PEELED OFF NEAR THE DISTAL END. THERE ALSO SCRATCHES OBSERVED ALONG THE MAIN TUBE. ON (B)(4) 2013, ISI CONTACTED THE INITIAL REPORTER AND VERIFIED THAT NO FRAGMENTS FELL INTO A PATIENT. HE ALSO DENIED THAT ANY PATIENTS WERE HARMED OR INJURED BECAUSE OF THE REPORTED ISSUE. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE REPORTED MAIN TUBE DAMAGE ISSUE 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 SURGICAL STAFF ALLEGEDLY NOTICED THAT THE THORACIC GRASPER INSTRUMENT HAD A DAMAGED TUBE. THE REPORTED ISSUE WAS FOUND DURING SET UP AND THE INSTRUMENT WAS NOT USED IN THE PLANNED PROCEDURE. THERE WERE NO MISSING OR FALLEN PIECES REPORTED. THERE WAS NO ALLEGATION OF ANY HARM, INJURY, OR ADVERSE OUTCOME TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114006 THORACIC GRASPER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420343-01 S10120823 022

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SURGICAL SYSTEM AND ACCESSORIES