BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE VERSAPOINT II BIPOLAR ELECTROSURGERY SYSTEM

    MDR report key: 3843241 · Received June 2, 2014

    Report

    Report Number
    2210968-2014-06926
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 14, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    HIH
    PMA / PMN Number
    K111751
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFO DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ELECTROSURGICAL PROCEDURE ON (B)(6) 2014. DURING THE PROCEDURE, THE LOOP OF THE RESECTOR ELECTRODE FIRST BENT AND SUBSEQUENTLY BROKE OFF. AN ADDITIONAL INTERVENTION TO RETRIEVE THE LOST PIECE WAS INTERRUPTED. CURRENTLY, A 3/4MM PIECE REMAINS IN THE PATIENT AND HAS NOT BEEN REMOVED. THE SURGEONS ARE HAVING A CLINIC EVALUATION TO REMOVE IT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321664 GYNECARE VERSAPOINT II BIPOLAR ELECTROSURGERY SYSTEM COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR HIH ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R