BEUDAMED
    FDA Adverse Event Other Summary report: N

    CER-VIEW

    MDR report key: 820039 · Received January 23, 2007

    Report

    Report Number
    1216677-2006-00018
    Event Type
    Other
    Date Received
    January 23, 2007
    Date of Event
    August 15, 2006
    Report Date
    January 23, 2007
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HDL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS NOT RETURNED. THE DIRECTIONS FOR USE STATE THE INSTRUMENT SHOULD BE THOROUGHLY EXAMINED TO ASSESS THE INTEGRITY OF THE ROSE COATING. ANY FLAWS SUCH AS CRACKS, TEARS OR CHIPS WOULD DISQUALIFY THE INSTRUMENT FOR USE. IT IS NOT KNOWN WHICH TYPE OF ELECTROSURGICAL GENERATOR WAS USED NOR IF THE PROPER SETTINGS FOR THE SUBJECT ELECTROSURGICAL GENERATOR WERE USED. NO CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    AT COMPLETION OF LEEP PROCEDURE, BILATERAL VAGINAL SIDEWALL BURNS NOTED ALONG PATH OF SIDEWALL RETRACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CER-VIEW LATERAL WALL RETRACTOR HDL COOPERSURGICAL, INC. F410 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention