BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 1063556 · Received June 20, 2008

    Report

    Report Number
    2955842-2008-01086
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    May 27, 2008
    Report Date
    June 20, 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

    THE INSTRUMENT HAS NOT BEEN RETURNED TO ISI FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED OR IF ADDITIONAL INFO IS REC'D.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A DA VINCI S MYOMECTOMY PROCEDURE METAL SHARDS WERE OBSERVED ON THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT. WHEN THE SITE ATTEMPTED TO REMOVE THE INSTRUMENT FROM THE TROCAR, IT WOULD NOT COME OUT, THEREFORE, THE INSTRUMENT AND TROCAR WERE REMOVED CONCURRENTLY FROM THE PT. THE PLANNED SURGICAL PROCEDURE WAS DELAYED, HOWEVER, IT WAS COMPLETED WITH A REPLACEMENT. NO PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ELECTROSURGICAL INSTRUMENT GEI INTUITIVE SURGICAL, INC. 420205-03 2304071 466

    Patients

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