BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Q2000 ELECTROSURGICAL GENERATOR

    MDR report key: 2097796 · Received April 12, 2011

    Report

    Report Number
    1216677-2011-00005
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    April 19, 2011
    Report Date
    May 4, 2011
    Manufacturer
    COOPERSURGICAL, INC., ALSO TRADING AS WALLACH SURGICAL DEVICES
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE MADE THE DETERMINATION THAT A USER ERROR WAS THE CAUSE OF THE EVENT. (B)(4).

    Description of Event or Problem · 1

    PT WAS ON THE TABLE AND THE UNIT DID NOT CUT. ON (B)(6) 2011 THE DR'S OFFICE CALLED AND TOLD US THERE WAS PT INVOLVEMENT. THE PT WAS GIVEN ANESTHESIA AND THE DR TRIED TO PERFORM THE PROCEDURE. WHEN SHE COULDN'T GET IT TO CUT, SHE TRIED TO CUT IN THE COAG MODE, BUT IT WAS DRAGGING THROUGH THE TISSUE AND SHE HAD TO ABANDON THE PROCEDURE. IT WAS NEVER COMPLETED. THE PT COMPLAINED OF PAIN AND DISTRESS AND PULLED HER RECORDS FROM THE DR'S OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Q2000 ELECTROSURGICAL GENERATOR NONE GEI COOPERSURGICAL, INC., ALSO TRADING AS WALLACH SURGICAL DEVICES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention