BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCHERTEL GRASPER INSTRUMENT

    MDR report key: 3627564 · Received February 13, 2014

    Report

    Report Number
    2955842-2014-00883
    Event Type
    Malfunction
    Date Received
    February 13, 2014
    Date of Event
    December 31, 2013
    Report Date
    February 5, 2014
    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. FAILURE ANALYSIS INVESTIGATION WAS UNABLE TO CONFIRM THE CUSTOMER REPORTED FAILURE MODE. UPON INSPECTION THE TWO GRIPS WERE ALIGNED. AN ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS THAT THE MAIN TUBE INSULATION EXHIBITED VARIOUS SCRATCH MARKS WITH MATERIAL REMOVAL. THE SCRATCHES MEASURED APPROXIMATELY .072- .244 IN LENGTH. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE DAMAGE TO THE INSTRUMENT'S MAIN TUBE FOUND DURING FAILURE ANALYSIS INVESTIGATION COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI PULMONARY LOBECTOMY PROCEDURE, THE CUSTOMER NOTED THAT THE SCHERTEL GRASPER INSTRUMENT TIPS WERE NOT ALIGNED. NO MISSING OR FALLEN PIECES WERE REPORTED. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. THE SURGERY WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96037 SCHERTEL GRASPER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420139-05 S10131023 867

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR