BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIEGMANN-GOFF ENDOSCOPIC LIGATOR

    MDR report key: 8442 · Received February 25, 1994

    Report

    Report Number
    38621-1994-00122
    Event Type
    Injury
    Date Received
    February 25, 1994
    Report Date
    January 31, 1994
    Manufacturer
    SUPERIOR HEALTH CARE GROUP, INC.
    Product Code
    MND
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    AN INTERNATIONAL NURSE INDICATES THAT WITH THE LIGATING BAND ATTACHED TO AN ENDOSCOPE, AND IN A PT'S ESOPHAGUS, THE BAND CARTRIDGE RELEASED FROM THE TRIP WIRE AND FELL INTO THE PT'S STOMACH. A PAIR OF FORCEPS WAS INTRODUCED DOWN THE ENDOSCOPE AND THE CARTRIDGE RETRIEVED WITHOUT FURTHER CONSEQQUENCE TO THE PT.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STIEGMANN-GOFF ENDOSCOPIC LIGATOR Implant LIGATOR MND SUPERIOR HEALTH CARE GROUP, INC. 88DDL020

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention