BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 1022778 · Received March 28, 2008

    Report

    Report Number
    2955842-2008-00174
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Report Date
    March 28, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING FOUND THE BOTTOM PLUG RISER PIN IS BENT SO THAT THE TOP AND BOTTOM PINS ARE NOT PARALLEL. AS A RESULT, A BIPOLAR CORD CANNOT BE ATTACHED TO THE INSTRUMENT. IT WAS DETERMINED THAT THE DAMAGE WAS MOST LIKELY DUE TO MISHANDLING WHERE AN IMPACT FORCE ON PIN LIKELY CAUSED BENDING. ENGINEERING ALSO OBSERVED THE DISTAL END OF MAIN TUBE HAS A COUPLE SECTIONS PARALLEL TO THE TUBE AXIS WITH LIGHT MATERIAL REMOVAL. SECTIONS ARE ROUGHLY 1.5" AND 1.8" LONG, 180 DEGREES APART. WEAR PATTERN IS CONSISTENT WITH CANNULA RELATED TUBE ABRASIONS. NO OTHER DAMAGE FOUND. ADD'L INVESTIGATION IS UNDERWAY REGARDING THE CANNULA ACCESSORIES. A F/U MDR WILL BE SUBMITTED IF ADD'L INFO IS REC'D.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S RADICAL PROSTATECTOMY SURGICAL PROCEDURE, THE PINS AT THE END OF THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WERE NOT "OK" AND THE BIPOLAR CABLE COULD NOT BE USED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH A REPLACEMENT INSTRUMENT. NO PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARYLAND BIPOLAR FORCEPS INSTRUMENT ELECTROSURGICAL INSTRUMENT GEI INTUITIVE SURGICAL, INC. 420172-06 1209071 269

    Patients

    Seq Age Sex Outcome Treatment
    1 ELECTROSURGICAL UNIT| DA VINCI S SURGICAL SYS| ACCESSORIES