BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTER, FOR 00241 TO PEDRIATIC SHEATHS

    MDR report key: 21618821 · Received March 17, 2025

    Report

    Report Number
    3011050570-2025-00255
    Event Type
    Malfunction
    Date Received
    March 17, 2025
    Date of Event
    December 16, 2024
    Report Date
    March 17, 2025
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    HIH
    PMA / PMN Number
    K890328
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE CUSTOMER¿S ALLEGATION WAS NOT CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, A PROBABLE ROOT CAUSE COULD NOT BE IDENTIFIED. DURING EVALUATION, IT WAS OBSERVED THAT THE SHAFT WAS SLIGHTLY BENT AT ITS DISTAL SECTION. THE ELECTRODE TIP WAS DISCOLORED AS SIGN OF USE. HOWEVER, THERE WAS NO VISUAL DAMAGE ON ITS GREEN INSULATION AND CONNECTOR. THE GREEN OUTER SHEATH COULD BE SLID BACK AND FORTH SMOOTHLY. WHEN BEING CLOSED, THERE WAS NO GAP BETWEEN THE BALL TIP AND INSULATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO PROVIDE A CORRECTION TO PREVIOUSLY SUBMITTED REPORT AND ADDITIONAL INFORMATION. CORRECTED: H3: H10: 3011050570-2025-00112 (1 OF 3), 3011050570-2025-00255 (2 OF 3) AND 3011050570-2025-00256 (3 OF 3). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INSULATION ON THE SUBJECT DEVICE HAD FALLEN AWAY FROM THE BALL ELECTRODE TIP. THE ISSUE OCCURRED DURING INSTALLATION. UPON RECEIPT OF THE RETURNED DEVICE, TWO (2) ADDITIONAL DEVICES WERE RECEIVED AND REPORTED TO BE INVOLVED IN THE EVENT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT. THIS REPORT 2 OF 3.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14393 ADAPTER, FOR 00241 TO PEDRIATIC SHEATHS HYSTEROSCOPE (AND ACCESSORIES) HIH GYRUS ACMI, INC. 245 JT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown