BEUDAMED
    FDA Adverse Event Summary report: N

    E.S.U. COAG. MACHINE

    MDR report key: 27616 · Received August 11, 1995

    Report

    Report Number
    27616
    Date Received
    August 11, 1995
    Report Date
    May 22, 1995
    Manufacturer
    UNISURGE INC.
    Product Code
    GEI
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    THE UNIT CUT WHEN "COAG" WAS PRESSED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. 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.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER 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 E.S.U. COAG. MACHINE COAG MACHINE GEI UNISURGE INC. GS 5600 000190

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Invalid Data