BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCEL CONMED PNEUMOPERITONEUM INSUFF NEEDLE

    MDR report key: 846195 · Received May 8, 2007

    Report

    Report Number
    1320894-2007-00095
    Event Type
    Injury
    Date Received
    May 8, 2007
    Date of Event
    March 23, 2007
    Report Date
    May 8, 2007
    Manufacturer
    CONMED CORP.
    Product Code
    FHO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS DISCARDED AT THE HOSPITAL. A NEW UNUSED DEVICE OF THE SAME LOT CODE WAS RETURNED FOR EVALUATION. THE DEVICE PRODUCTION RECORDS WERE REVIEWED. THESE WERE FOUND TO BE CORRECT. THE DEVICE WAS VISUALLY EXAMINED AND FOUND TO BE ASSEMBLED CORRECTLY. IT WORKED AS STATED IN THE PRODUCT INSERT. THE REPORT INDICATED THAT THE PERFORATIONS OCCURED BECAUSE THE SURGEON "DID NOT HEAR THE CLICK." THE PRODUCT INSERT IS INCLUDED AS PAGE 3 OF 3. THERE IS NO INDICATION THAT THE DEVICE IS SOLD AS AN AUDIBLE DEVICE. THE INSERT REFERENCES THE SURGEON "FEELING A CLICK" WHEN INSERTING THE NEEDLE. THE RETURNED DEVICE WORKED AS DESIGNED TO. WE FEEL THE PERFORATION MOST LIKELY OCCURED DUE TO AN ERROR IN THE SURGEON'S TECHNIQUE FOR JUDGING THE NEEDLE PLACEMENT AND THE INSERTION DEPTH. WE CONSIDER THIS COMPLAINT CLOSED AND THE INVESTIGATION COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DURING A LAVH, THE SURGEON PERFORATED THE BOWEL AND THE MESENTERY MEMBRANE. BOTH WERE REPAIRED IMMEDIATELY DURING THE SURGICAL PROCEDURE. THE PROCEDURE WAS NOT ALTERED. THE STATUS OF THE PATIENT WAS REPORTED AS, "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCEL CONMED PNEUMOPERITONEUM INSUFF NEEDLE DISPOSABLE INSUFFLATION NEEDLE FHO CONMED CORP. NA 0603271

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention