BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAY LOOP APPLICATOR

    MDR report key: 25349 · Received July 18, 1994

    Report

    Report Number
    1418479-1994-09086
    Event Type
    Malfunction
    Date Received
    July 18, 1994
    Date of Event
    June 24, 1994
    Report Date
    June 30, 1994
    Manufacturer
    R. WOLF, GMBH
    Product Code
    HET
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS PERFORMING A LAPAROSCOPIC TUBAL OCCLUSION WITH BANDS. THE INSSTRUMENT WOULD NOT DISENGAGE THE BANDS FROM THE FALLOPIAN TUBE. MINOR BLEEDING ONLY, OCCURRED. BLEEDING WAS STOPPED AND THE CASE WAS COMPLETED USING ELECTRO-CAUTERIZATION.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. 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 LAY LOOP APPLICATOR LAPAROSCOPIC FALLOPIAN RING APPLICATOR HET R. WOLF, GMBH 8388.87 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other