BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENNACULUM FORCEPS INSTRUMENT

    MDR report key: 1170799 · Received September 12, 2008

    Report

    Report Number
    2955842-2008-01274
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    August 19, 2008
    Report Date
    September 12, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS BEEN RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING FOUND THE INSTRUMENT IS BROKEN AT THE PROXIMAL CLEVIS TO MAIN TUBE INTERFACE WITH THE CLEVIS DISLODGED FROM THE MAIN TUBE AS A RESULT. BOTH THE PROXIMAL CLEVIS AND MAIN TUBE ARE MISSING PIECES. BASED ON THE ENGINEERING EVALUATION, A LIKELY FAILURE MODE WAS OVERLOADING OF THE INSTRUMENT AT THE TIP, CAUSING THE BREAKAGE. PER THE CASE NOTES. THE BROKEN INSTRUMENT COMPONENTS WERE SUCCESSFULLY RETRIEVED FROM THE PT. THE FOLLOWING MEDWATCH REPORT LISTED BELOW WAS ALSO SENT TO THE FDA FOR THE FIRST TENNACULUM FORCEPS INSTRUMENT USED DURING THE SURGICAL PROCEDURE. MFR REPORT #2955842-2008-01273.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 20 MINS INTO A DA VINCI MYOMECTOMY PROCEDURE, WHILE THE SURGEON WAS REMOVING A FIBROID, THE TENNACULUM FORCEPS INSTRUMENT CLEVIS BROKE AND A PIECE FELL INTO THE PT. THE BROKEN PIECE WAS IMMEDIATELY RETRIEVED AND THE PROCEDURE CONTINUED WITH A REPLACEMENT TENNACULUM FORCEPS INSTRUMENT. WHILE USING THE SECOND TENNACULUM FORCEPS INSTRUMENT THE CLEVIS BROKE AND A PIECE FELL INTO THE PT. THE BROKEN PIECE WAS RETRIEVED AND THE SURGICAL PROCEDURE CONTINUED WITH A THIRD REPLACEMENT TENNACULUM FORCEPS INSTRUMENT. THE PLANNED SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED AND NOT SIGNIFICANTLY LENGTHENED. NO PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENNACULUM FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT GCJ INTUITIVE SURGICAL, INC 400207-05 1406061 038

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI SURGICAL SYSTEM| ACCESSORIES