BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTROSURGICAL UNITS, SPECIALTY

    MDR report key: 136150 · Received December 5, 1997

    Report

    Report Number
    136150
    Event Type
    Injury
    Date Received
    December 5, 1997
    Date of Event
    October 28, 1997
    Report Date
    November 26, 1997
    Manufacturer
    MARKET-TIERS INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD DIAGNOSTIC LAPAROSCOPY AND ENDOTHERMAL COAGULATION OF ENDOMETRIOSIS IMPLANTS 10/28/97. RETURNED TO HOSPITAL & SURGERY 11/15/97 WITH PERFORATION OF RETURN ALLEGEDLY DUE TO ELECTROTHERMAL INJURY. - HARTMAN PROCEDURE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTROSURGICAL UNITS, SPECIALTY ENDO-COAGULATOR GEI MARKET-TIERS INC. 7500(UNIT); 7515-1 (PROBE) *

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization| R