BEUDAMED
    FDA Adverse Event Other Summary report: N

    KLI

    MDR report key: 570708 · Received January 26, 2005

    Report

    Report Number
    570708
    Event Type
    Other
    Date Received
    January 26, 2005
    Report Date
    January 26, 2005
    Manufacturer
    ACMI CORPORATION
    Product Code
    KNS
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE BIPOLAR FORCEPS WAS INTACT. DURING THE ELECTIVE STERILIZATION PROCEDURE, (LAPAROSCOPIC TUBAL LIGATION) THE KLEPPINGER BIPOLAR INSTRUMENT CAME APART WHILE INSIDE THE PATIENT ATTACHED TO THE FALLOPIAN TUBE. THIS RESULTED ON THE INSTRUMENT LOCKING ON THE TUBE. THE INSTRUMENT COULD BE REMOVED WITHOUT CAUSING INJURY TO THE PATIENT OR A NEED FOR AN ADDITIONAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KLI BIPOLAR CAUTERY FORCEP KNS ACMI CORPORATION 002707-501 *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR