BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7MM EXTENDED LENGTH ENDOSCOPE

    MDR report key: 22932119 · Received September 2, 2025

    Report

    Report Number
    2242352-2025-0001011
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    August 6, 2025
    Report Date
    September 30, 2025
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GCJ
    UDI-DI
    00607567700802
    PMA / PMN Number
    K014250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TW # (B)(4). UPDATED SECTIONS: B4, B5, G3, G6, H2, H3, H6, H11. CORRECTED SECTION: H3-CHANGED TO DEVICE NOT RETURNED. THE REPORTED DEVICE IS AN OEM DEVICE. THE CERTIFICATE OF CONFORMANCE WAS REVIEWED FOR THE SERIAL # (B)(6). THE VENDOR CERTIFIES THAT THIS DEVICE LOT CONFORMS TO ALL APPLICABLE PRODUCT SPECIFICATIONS AND THERE WERE NO NON-CONFORMANCES IDENTIFIED FOR THE MANUFACTURING BATCH.

    Additional Manufacturer Narrative · 0

    (B)(4). SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. EVENT SITE NAME EXCEEDS CHARACTER LIMITATIONS: (B)(6).

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT OPTIC C-VH-1111 SN (B)(6), WHICH IS IN OUR WAREHOUSE AS CONSUMABLES, HAS BEEN REPORTED AS DEFECTIVE. THE OPTICS ARE CLOUDY/MILKY BUT WILL CONTINUE TO BE USED FOR EVH UNTIL THE CUSTOMER PURCHASES/REPLACES THEM. THE RESTRICTION IS NOT THAT SERIOUS, AND THE OPTICS ARE NEEDED. THE OPTICS ARE CURRENTLY BEING USED AS CONSIGNMENT GOODS BY GETINGE GERMANY AT THE (B)(6) HOSPITAL.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT OPTIC C-VH-1111 SN (B)(6), HAS BEEN REPORTED AS DEFECTIVE. THE OPTICS ARE CLOUDY/MILKY BUT WILL CONTINUE TO BE USED FOR EVH UNTIL THE CUSTOMER PURCHASES/REPLACES THEM. THE RESTRICTION IS NOT THAT SERIOUS, AND THE OPTICS ARE NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2223092 7MM EXTENDED LENGTH ENDOSCOPE LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ MAQUET CARDIOVASCULAR LLC VH-1111 00607567700802

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown