BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUFEX

    MDR report key: 972 · Received July 1, 1992

    Report

    Report Number
    972
    Event Type
    Malfunction
    Date Received
    July 1, 1992
    Date of Event
    April 6, 1992
    Report Date
    April 20, 1992
    Manufacturer
    ACUFEX MICROSURGICAL, INC.
    Product Code
    DQR
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS USING THIS DEVICE ON PATIENTS' LEFT KNEE. WHEN MANIPULATING THE CANNULA IT BROKE WHILE IN THE KNEEINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. 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: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUFEX DQR ACUFEX MICROSURGICAL, INC. 000160

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other