BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIEGMANN-GOFF ENDOSCOPIC LIGATOR

    MDR report key: 3497 · Received April 14, 1993

    Report

    Report Number
    32838-1993-00035
    Event Type
    Injury
    Date Received
    April 14, 1993
    Report Date
    February 16, 1993
    Manufacturer
    SUPERIOR HEALTH CARE GROUP, INC.
    Product Code
    KNQ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NS
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE NURSE STATES THAT A PATIENT PRESENTED IN JANUARY, 1993 FOR ESOPHAGEAL LIGATION. THE BANDING CARTIDGE WASPLACED ON THE ENDOSCOPE AND INSERTED DOWN THE ESOPHAGUS. AFTER PLACING THE CARTRIDGE ON THE VARIX, THE TRIP WIRE WAS PULLED TO DEPLOY THE BAND. THE DISTAL BEAD CAME OFF THE TRIP WIRE AND THE CARTRIDGE RELEASED FROM THE ENDOSCOPE AND INTO THE ESOPHAGUS. THE CARTRIDGE WAS ENDOSCOPICALLY RETREIVED USING A SNARE. THERE WAS NO FURTHER PATIENT COMPLICATIONSINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STIEGMANN-GOFF ENDOSCOPIC LIGATOR LIGATOR KNQ SUPERIOR HEALTH CARE GROUP, INC. 200220 26IAL607

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention