BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPSY FORCEPS, SPOON TYPE, OPTICAL, FOR 30° TELESCOPE

    MDR report key: 23510882 · Received November 10, 2025

    Report

    Report Number
    9610773-2025-06927
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Report Date
    January 21, 2026
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GCP
    UDI-DI
    04042761020015
    PMA / PMN Number
    K790071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: D9, H3, H6, H11 THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS NOT CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, A PROBABLE ROOT CAUSE COULD NOT BE IDENTIFIED. 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

    THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE JEWS ARE STICKING. THE ISSUE WAS FOUND DURING REPROCESSING. NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2543372 BIOPSY FORCEPS, SPOON TYPE, OPTICAL, FOR 30° TELESCOPE A20713A GCP OLYMPUS WINTER & IBE GMBH A20713A 04042761020015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown