BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-MAX CUTTING LOOP

    MDR report key: 3102129 · Received April 26, 2013

    Report

    Report Number
    1018233-2013-01609
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 27, 2013
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD
    Product Code
    FAS
    PMA / PMN Number
    PRE AM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN STILL IN PROGRESS. A SUPPLEMENTAL WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE WHERE THE GYNECOLOGIST REMOVED UTERINE POLYPS, THE CUTTING LOOP HOOK DETACHED AND REMAINED LODGED IN THE UTERUS. THE PT HAD A LAPAROSCOPIC PROCEDURE UNDER FLUOROSCOPY AND THE PHYSICIAN WAS ABLE TO RECOVER THE HOOK. THE PT HAD GENERAL ANESTHESIA THROUGHOUT THE PROCESS AND THIS ISSUE INCREASED OPERATIVE TIME BY 45 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181971 C-MAX CUTTING LOOP FAS PRODUCTOS PARA EL CUIDADO DE LA SALUD NA NGWK3173

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention