BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 1022782 · Received March 28, 2008

    Report

    Report Number
    2955842-2008-00179
    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
    OR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED DISTAL END OF THE MAIN TUBE HAS A .175" X .120" OBLONG HOLE BURNED THROUGH IT. TUBE EXHIBITS LOCALIZED CHARRING/MELTING, INDICATING AN ARCING EVENT OCCURRED. INSTRUMENT WAS DISASSEMBLED TO FIND THE TUBE EXTENSION SEAL MELTED IN THE SAME LOCATION AS THE MAIN TUBE, WITH ONE OF THE HYPOTUBES DIRECTLY BELOW THE TUBE EXTENSION HAVING CHARRED MATERIAL ON IT. MAIN TUBE HAS A CRACK PARALLEL TO THE TUBE AXIS DIRECTLY BELOW THE HOLE THAT RUNS ALL THE WAY DOWN THE TUBE, CREATING A PATHWAY FOR ARCING TO OCCUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MONOPOLAR CURVED SCISSOR INSTRUMENT DID NOT WORK. NO ADDITIONAL INFO WAS PROVIDED. NO PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR CURVED SCISSORS INSTRUMENT ELECTROSURGICAL INSTRUMENT GEI INTUITIVE SURGICAL, INC. 420179-08 1608071 173

    Patients

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