BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPSY FORCEPS, 7 FR., SEMIFLEXIBLE

    MDR report key: 23215802 · Received October 3, 2025

    Report

    Report Number
    9610773-2025-06177
    Event Type
    Malfunction
    Date Received
    October 3, 2025
    Date of Event
    September 5, 2025
    Report Date
    November 14, 2025
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    NWW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: B5, D8, D10, H2, H3, H6, H11. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: THE HANDLE CANNOT CONTROL THE OPENING AND CLOSING OF THE FORCEPS, AND THE PINS WERE MISSING. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE OF THE MALFUNCTION FOUND DURING DEVICE EVALUATION IS TRACED TO COMPONENT FAILURE. 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 SUBJECT DEVICE EXPERIENCED AN ABNORMAL OPENING AND CLOSING OF THE BIOPSY FORCEPS.THE ISSUE OCCURRED DURING SET UP/ INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233672 BIOPSY FORCEPS, 7 FR., SEMIFLEXIBLE A4832 NWW OLYMPUS WINTER & IBE GMBH A4832

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown