BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 2970427 · Received February 20, 2013

    Report

    Report Number
    2955842-2013-00555
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 21, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING WAS UNABLE TO CONFIRM THE CUSTOMER REPORTED FAILURE MODE. THE INSTRUMENT PASSED RECOGNITION AND ENGAGEMENT TESTING WHEN TESTED ON AN ISI IN-HOUSE IS3000 SYSTEM. THE INSTRUMENT MOVED INTUITIVELY WITH A FULL RANGE OF MOTION IN ALL DIRECTIONS, THE GRIPS OPENED AND CLOSED PROPERLY AND PERFORMED CAUTERY FUNCTION WITH NO TROUBLE FOUND. ON (B)(6) 2013, ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE THAT WAS PRESENT DURING THE SURGICAL PROCEDURE. THE CSR INDICATED THAT APPROXIMATELY 30 - 40 MINUTES INTO THE SURGICAL PROCEDURE, WHILE THE SURGEON WAS GRASPING TISSUE THAT WAS BEING DISSECTED FOR REMOVAL, THE SURGEON OBSERVED ENERGY COMING FROM THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WITHOUT ANY ACTIVATION OF CAUTERY ENERGY FROM THE FOOT PEDAL ON THE SURGEON SIDE CART (SSC). THE CSR INDICATED THAT THE SITE PERFORMED TROUBLESHOOTING OF THE ISSUE AND WHEN THE SURGEON ATTEMPTED TO GRASP TISSUE A 2ND TIME, THE ISSUE RECURRED. THE CSR INDICATED ENERGY ACTIVATED A 3RD TIME FROM THE INSTRUMENT WHEN THE SURGEON DEMONSTRATED TO HIM WHAT HAD OCCURRED DURING TROUBLESHOOTING. THE CSR INDICATED THAT THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS IMMEDIATELY REPLACED AND THE ISSUE WAS RESOLVED. THE CSR INDICATED THAT A VALLEY LAB FORCE TRIAD ELECTRICAL SURGICAL UNIT (ESU) AND A VALLEY LAB DISPOSABLE ESU CABLE WERE USED IN CONJUNCTION WITH THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT. THE CSR INDICATED THAT IT IS UNKNOWN IF THE SITE INSPECTED THE ESU PRIOR TO USE; HOWEVER, THE SITE DID INSPECT THE ESU DURING TROUBLESHOOTING AND FOUND THAT THE ESU CABLE WAS INSTALLED PROPERLY. THE CSR INDICATED THAT THE SETTINGS ON THE SSC WERE CORRECT AND THAT THE SURGICAL PROCEDURE WAS NOT RECORDED. THE CSR INDICATED THAT THE SURGICAL PROCEDURE WAS COMPLETED AND THERE WAS NO IMPACT TO THE PATIENT, EXCEPT TO THE TISSUE BEING REMOVED AS PART OF THE SURGICAL PROCEDURE. THE CSR ALSO INDICATED THAT THERE WAS NO REPORT BY THE SURGEON THAT THE PATIENT EXPERIENCED ANY POST-SURGICAL COMPLICATIONS AS A RESULT OF THE REPORTED EVENT. ON (B)(6) 2013, THE SITE'S DA VINCI SI SURGICAL SYSTEM WAS EVALUATED BY AN ISI FIELD SERVICE ENGINEER. THE FSE WAS UNABLE TO REPLICATE THE FAILURE MODE EXPERIENCED BY THE SITE AS INSPECTION OF THE SITE'S SURGICAL SYSTEM FOUND THAT IT FUNCTIONED WITHIN SPECIFICATIONS. AS OF (B)(6) 2013, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT ACTIVATED WITHOUT THE SURGEON ACTIVATING CAUTERY ENERGY FROM THE FOOT PEDAL ON THE SURGEON SIDE CART. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74904 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 M10120613 768

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI SI SURG. SYSTEM, ACCESSORIES AND AN ESU.