BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROSURGICAL GENERATOR (E.S.U.)

    MDR report key: 7499 · Received January 9, 1994

    Report

    Report Number
    7499
    Event Type
    Malfunction
    Date Received
    January 9, 1994
    Date of Event
    August 24, 1993
    Report Date
    September 21, 1993
    Manufacturer
    VALLEYLAB, INC.
    Product Code
    FEH
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    DURING ERCP SPKINECTOMEY, DR. HAD CAUTERY SETTINGS ON COAG #3 AND CUT #3. AFTER SEVERAL ATTEMPTS AT TRYING TO CUT THE PANCREATIC AND COMON BILE DUCT. DR. ORDER INCREASE CUT LEVEL TO #4. AFTER SEVERAL ATTEMPTS PER DR., ON THE 4TH ATTEMPT STATED "IT CUT TOO MUCH" ABDOMINAL X-RAY TAKEN. PATIENT TO CCU. EXPLORATORY SURGERY LATER THAT EVENING.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-APR-93. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTROSURGICAL GENERATOR (E.S.U.) N/A FEH VALLEYLAB, INC. SSE2L N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other