BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST ONE VESSEL SEALER INSTRUMENT

    MDR report key: 4620068 · Received March 20, 2015

    Report

    Report Number
    2955842-2015-00453
    Event Type
    Malfunction
    Date Received
    March 20, 2015
    Date of Event
    February 23, 2015
    Report Date
    February 24, 2015
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K140189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION WAS NOT ABLE TO CONFIRM THE ALLEGED SEALING ISSUE. THE INSTRUMENT WAS RECEIVED IN DAMAGED CONDITION. FAILURE ANALYSIS WAS NOT ABLE TO TEST THE INSTRUMENT. VISUAL INSPECTION SHOWED THAT THE INSTRUMENT HAD BEEN AUTOCLAVED. THERE WAS NO OBVIOUS DAMAGE TO THE INSTRUMENT TIPS, HOWEVER THE STRAIN RELIEF WAS FOUND TO BE MELTED. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF TO REOCCUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SURGICAL PROCEDURE, THE ENDOWRIST ONE VESSEL SEALER INSTRUMENT WOULD NOT SEAL. ON (B)(4) 2015, INTUITIVE SURGICAL INC., (ISI) OBTAINED THE FOLLOWING INFORMATION: DURING THE PROCEDURE, THE SURGEON WAS UNABLE TO SEAL. THE SURGEON WOULD HEAR THE BEEPS/SOUND HOWEVER NOTED THAT THERE WAS NO BURNING OR TISSUE EFFECT. THE TISSUE THAT THE SURGEON WAS ATTEMPTING TO SEAL WAS THE SHORT GASTRIC ON THE LOWER STOMACH. THERE WERE NO ERROR MESSAGES THAT WERE OBSERVED. A NEW VESSEL SEALER INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF 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
    190901 ENDOWRIST ONE VESSEL SEALER INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 480322-04 S10141205 0211

    Patients

    Seq Age Sex Outcome Treatment
    1