BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNER SHEATH, FOR 26 FR. OUTER SHEATH

    MDR report key: 19923451 · Received August 6, 2024

    Report

    Report Number
    3003724334-2024-00277
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Date of Event
    July 21, 2024
    Report Date
    August 12, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HIH
    UDI-DI
    04042761029339
    PMA / PMN Number
    K931994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL PMA/510(K) NUMBER: K931995.

    Additional Manufacturer Narrative · 0

    CORRECTION - IN THE INITIAL REPORT THE FACILITY WAS LISTED AS BERLIN (3003724334) WHEN THE FACILITY SHOULD HAVE BEEN HAMBURG (9610773). UPDATES WERE MADE TO SECTION D3 AND G1B. TO REFLECT THIS CORRECTION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THE INNER SHEATH, FOR 26 FR. OUTER SHEATH CERAMIC TIP WAS LOOSE. THE REPORTED ISSUE WAS DISCOVERED DURING REPROCESSING. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1561982 INNER SHEATH, FOR 26 FR. OUTER SHEATH HYSTEROSCOPE (AND ACCESSORIES) HIH OLYMPUS WINTER & IBE GMBH A22040A 178W-0247 04042761029339

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown