BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUFEX

    MDR report key: 4294 · Received July 28, 1992

    Report

    Report Number
    4294
    Event Type
    Injury
    Date Received
    July 28, 1992
    Date of Event
    January 17, 1992
    Report Date
    February 12, 1992
    Manufacturer
    ACUFEX - MICROSURGICAL INC.
    Product Code
    GEA
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    AFTER MAINPULATING THE KNEE DURING THE SURGICAL PROCEDURE IT WAS OBSERVED THAT THE DISPOSABLE ACUFEX ARTHROSCOPY SHEATH HAD FRAGMENTED. ALL OBSERVABLE PIECES WERE REMOVED FROM THE KNEEDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. 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: YES. CORRECTIVE ACTIONS: DEVICE DISCARDED. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUFEX UNIVERSAL CANNULA KIT WITH OBTURATION GEA ACUFEX - MICROSURGICAL INC. 012419 000229

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention