BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KLI ELECTRO-GYNE ELECTROSURGICAL GENERATOR

    MDR report key: 99225 · Received June 17, 1997

    Report

    Report Number
    2020483-1997-00002
    Event Type
    Injury
    Date Received
    June 17, 1997
    Date of Event
    May 9, 1997
    Report Date
    June 11, 1997
    Manufacturer
    CIRCON CORP.
    Product Code
    KNF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED UNIT WAS INITIALLY TESTED AND FOUND TO HAVE THE OUTPUT POWER IN THE MONOPOLAR MODE LOWER THAN SPECIFIED. WHEN A RETEST WAS PERFORMED (IN ORDER TO VIDEO TAPE THE TESTING AT THE REQUEST OF THE CUSTOMER) THE UNIT FAILED TO DELIVER ANY OUTPUT IN BOTH THE MONOPOLAR AND BIPOLAR MODES. THE INITIAL TESTING RESULTS WERE FOUND TO BE UNRELATED TO THE INCIDENT. SINCE THE UNIT WAS NOT OPERATIONAL AFTER THE RETESTING, AND THE CUSTOMER DID NOT WANT ANY ALTERATIONS OR REPAIRS MADE ON THE UNIT, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    A LAPAROSCOPIC BILATERIAL TUBAL LIGATION WAS BEING PERFORMED ON A PT WHEN A THERMAL INJURY TO THE SIGMOID COLON OCCURRED. ACCORDING TO THE RISK MGR, THE THERMAL INJURY WAS A 1 CM X 1 CM BURN. THE PT HAD TO UNDERGO PARTIAL RESECTION OF THE COLON WITH PRIMARY ANASTOMOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KLI ELECTRO-GYNE ELECTROSURGICAL GENERATOR ELECTROSURGICAL GENERATOR KNF CIRCON CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention