BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 1191162 · Received September 26, 2008

    Report

    Report Number
    2955842-2008-01294
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Report Date
    September 26, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS/CONCLUSIONS - THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE INSTRUMENT WAS BROKEN AT THE PROXIMAL CLEVIS TO MAIN TUBE INTERFACE. THE CLEVIS IS DISLODGED FROM THE MAIN TUBE AS A RESULT OF THE BREAKAGE AND THE PROXIMAL CLEVIS AND MAIN TUBE ARE MISSING PIECES. PER THE CASE NOTES, THERE ARE NO INDICATIONS FROM THE SITE THAT THE MISSING INSTRUMENT COMPONENTS FELL INSIDE OF A PATIENT DURING A SURGICAL PROCEDURE. ENGINEERING ALSO OBSERVED TUBE ABRASIONS ON THE DISTAL END OF THE MAIN TUBE WHICH EXTEND APPROXIMATELY 5.75" AND IS LOCATED 1" FROM THE INTERSECTION BETWEEN THE PROXIMAL CLEVIS AND MAIN TUBE. THE DAMAGED AREA IS PARALLEL TO THE TUBE AXIS AND HAS A ROUGH SURFACE FINISH. BASED ON THE LOCATION AND APPEARANCE, THE DAMAGE WAS MOST LIKELY CAUSED BY A CANNULA ACCESSORY. NO OTHER DAMAGE FOUND. ADDITIONAL INVESTIGATION IS UNDERWAY REGARDING THE CANNULA ACCESSORIES. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS NOT WORKING PROPERLY. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARLAND BIPOLAR FORCEPS INSTRUMENT ELECTROSURGICAL INSTRUMENT GEI INTUITIVE SURGICAL, INC. 420172-04 2709061 185

    Patients

    Seq Age Sex Outcome Treatment
    1 DE VINCI S SURGICAL SYSTEM| ELECTROSURGICAL UNIT| ACCESSORIES