BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIBER-CYSTOSCOPE 15FR WL 400MM

    MDR report key: 18935553 · Received March 19, 2024

    Report

    Report Number
    9611102-2024-00012
    Event Type
    Injury
    Date Received
    March 19, 2024
    Date of Event
    February 16, 2024
    Report Date
    March 19, 2024
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    FAJ
    UDI-DI
    04055207013656
    PMA / PMN Number
    K980401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE MEDICAL SUPPLIER SOLD THE FIBER-CYSTOSCOPE 15FR WL 400MM, 7305.001, TO THE GENERAL HOSPITAL OF NIKAIA IN ATHENS IN JANUARY 2024 AND WAS USED FOR 25 CASES AFTER THE REPORTED INCIDENT HAPPENED. RWGMBH HAS BEEN PROVIDED INFORMATION VIA THE INCIDENT QUESTIONNAIRE THAT THE DEFECT DID NOT OCCURRED DURING THE USE OF THE DEVICE. ADDED, NO RISK TO PATIENT, USERS OR THIRD PARTIES. ALSO, INFORMATION REGARDING REPROCESSING, THAT LISTED TWO CHEMICALS THAT HAVE NOT BEEN TESTED AND/OR APPROVED BY RWGMBH. RWGMBH HAS REQUESTED THE RETURN OF THE PRODUCT FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    A MEDICAL SUPPLIER AND RICHARD WOLF GMBH (RWGMBH) HAS BEEN INFORMED OF AN ISSUE REGARDING AN FIBER-CYSTOSCOPE 15FR WL 400MM, PART ID: 7305.001, SN# (B)(6). ACCORDING TO THE RECEIVED INFORMATION, THE GENERAL HOSPITAL OF NIKAIA IN ATHENS REPORTED THREE SERIOUS INCIDENTS WITH PATIENTS DEVELOPING A SEVERE HYPOXEMIA, 10-15 MINUTES FOLLOWING CYSTOSCOPY. ONE OF THE PATIENT HAD TO BE TRANSFERRED TO THE INTENSIVE CARE UNIT. THESE HAPPENED ON (B)(6) JAN, (B)(6) FEB, AND (B)(6) 2024 RESPECTIVELY. THE CASES WERE STARTED AFTER THE USE OF THE INSTRUMENT. ALL PATIENTS ARE NOW DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536831 FIBER-CYSTOSCOPE 15FR WL 400MM FAJ RICHARD WOLF GMBH 7305001 04055207013656

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other