BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIEGMANN-GOFF ENDOSCOPIC LIGATOR

    MDR report key: 8431 · Received February 3, 1994

    Report

    Report Number
    1223688-1994-00074
    Event Type
    Injury
    Date Received
    February 3, 1994
    Date of Event
    December 15, 1993
    Report Date
    January 19, 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 PHYSICIAN INDICATES THAT A PT PRESENTED FOR AN ESOPHAGEAL LIGATION ON 12/15/93. THE CYLINDEER AND TRIP WIRE WERE ASSEMBLED AND CONNECTED TO THE ENDOSCOPE. WITH THE ENDOSCOPE DOWN THE PT'S ESOPHAGUS, THE CYLINDER FELL INTO THE PT'S STOMACH. THE CYLINDEEER WAS RETREIVED WITHOUT INCIDENT ENDOSCOPICALLY USING FORCEPS. NO FURTHER COMPLICATION WAS REPORTED.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 MND SUPERIOR HEALTH CARE GROUP, INC. 200220 88LCL006

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention