BEUDAMED
    FDA Adverse Event Other Summary report: N

    FENESTRATED BIPOLAR FORCEPS

    MDR report key: 2836577 · Received November 16, 2012

    Report

    Report Number
    2955842-2012-00966
    Event Type
    Other
    Date Received
    November 16, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 19, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ISI CONTACTED INITIAL REPORTER, REGISTER NURSE (B)(6). BASED ON THE INFORMATION PROVIDED BY (B)(6), DUAL CONSOLES WERE USED FOR THIS PROCEDURE, SURGEON DR (B)(6) WAS USING ONE CONSOLE AND THE RESIDENT SURGEON WAS USING THE SECOND CONSOLE. SHE INDICATED THAT THERE WAS A COLLISION BETWEEN THE FENESTRATED BIPOLAR INSTRUMENT USED BY DR (B)(6) AND THE PROGRASP INSTRUMENT USED BY THE RESIDENT SURGEON. AS THE SURGEONS ATTEMPTED TO SEPARATE BOTH INSTRUMENTS, THEY OBSERVED THAT THE FENESTRATED BIPOLAR FORCEPS JAW BROKE. IT TOOK APPROXIMATELY ONE HOUR TO LOCATE AND REMOVE THE BROKEN PIECE FROM THE PATIENT. AN X-RAY HAD TO BE PERFORMED TO LOCATE THE INSTRUMENT PIECE; THE PIECE WAS LOCATED IN THE PATIENT'S PELVIS. PATIENT DID NOT SUFFER ANY ADDITIONAL COMPLICATIONS FROM THIS INCIDENT OR FROM THE EXPOSURE TO ADDITIONAL ANESTHESIA. PATIENT WAS RELEASED FROM THE HOSPITAL AS PLANNED. THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE INSTRUMENT WAS RETURNED WITH ONE GRIP JAW BROKEN AT DISTAL CLEVIS GRIP BASE. A PIECE OF APPROXIMATELY 0.185 X 0.209 HAD BROKEN OFF FROM THE INSTRUMENT. THERE WAS NO DAMAGE FOUND ON THE CABLE OR THE WIRE. INSTRUMENT PASSED ELECTRICAL CONTINUITY TEST. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE BIPOLAR FORCEPS INSTRUMENT BROKE AND HALF OF THE JAW FELL INTO THE PATIENT. THE SURGEON WAS ABLE TO LOCATE THE BROKEN JAW PIECE IN THE PELVIS, THE PIECE WAS RETRIEVED AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FENESTRATED BIPOLAR FORCEPS ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 M10120813 710

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DA VINCI SI SYSTEM INSTRUMENTS| ACCESSORIES