BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE RADIAL JAW FORCEP

    MDR report key: 911 · Received July 22, 1992

    Report

    Report Number
    1219544-1992-00007
    Event Type
    Injury
    Date Received
    July 22, 1992
    Date of Event
    June 22, 1992
    Report Date
    July 2, 1992
    Manufacturer
    SYMBIOSIS
    Product Code
    FCL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    FOLLOW-UP WITH DR. BY PT. ON 6/26/92. DR. STATES THAT ON JUNE 22 HE PERFORMED A BIOPSY ON A HEALED GASTROINTESTINAL ULCER. AN ENDOSCOPE WAS PLACED TRANSORALLY AND THE RADIAL JAW WAS ADVANCED THROUGH THE SCOPE TO THE LESION. FIVE BITED WERE TAKEN. ONE OF THE BITES WAS EXCESSIVE CAUSING 10 CC OF OZZING, HOWEVER, HEMOSTATSIS OCCURRED SPONTANEOUSLY. THE PATIENT WAS DISCHARGED TO HOME THAT EVENING BUT PRESENTED TO THE HOSPITAL THE FOLLOWING DAY WITH A SIGNIFICANT G.I. BLEED. FIVE UNITS OF BLOOD WERE GIVEN. LATER THAT DAY A WELL FORMED CLOT WAS NOTED AT THE BIOPSY SITEDEVICE 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.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE RADIAL JAW FORCEP FORCEP FCL SYMBIOSIS UNKNOWN 2046546A

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention