BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIEGMANN-GOFF ENDOSCOPIC LIGATOR (10)

    MDR report key: 7239 · Received November 5, 1993

    Report

    Report Number
    32838-1993-00022
    Event Type
    Injury
    Date Received
    November 5, 1993
    Date of Event
    October 18, 1993
    Report Date
    October 21, 1993
    Manufacturer
    SUPERIOR HEALTH CARE GROUP, INC.
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE NURSE STATES THAT THE PHYSICIAN LOADED THE CYLINDER ONTO THE ENDOSCOPE WITH THE TRIP WIRE ATTACHED. ONCE THE ENDOSCOPE WAS DOWN THE PATIENT'S ESOPHAGUS AND ONTO A VARIX, THE PHYSICIAN PULLED ON THE TRIP WIRE. THE TRIP WIRE PULLED THROUGH THE CYLINDER CLIP AND THE CYLINDER FELL INTO THE ESOPHAGUS WIWTHOUT DISCHARGING THE BAND. THE PHYSICIAN RETREIVED THE CYLINDER WITHOUT PATIENT CONSEQUENCE USING BIOPSY FORCEPS.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT 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: 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 (10) LIGATOR SUPERIOR HEALTH CARE GROUP, INC. 88FDL049

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention