BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L-ANEURYSM-CLIP

    MDR report key: 24765298 · Received April 2, 2026

    Report

    Report Number
    8010890-2026-00001
    Event Type
    Malfunction
    Date Received
    April 2, 2026
    Date of Event
    April 1, 2026
    Report Date
    April 2, 2026
    Manufacturer
    PETER LAZIC GMBH
    Product Code
    HCH
    PMA / PMN Number
    K081489
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION IS CURRENTLY AVAILABLE BEYOND WHAT HAS ALREADY BEEN PROVIDED. WE ARE AWAITING THE RETURN OF THE PRODUCT FOR INSPECTION. WE ARE REQUESTING ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    CUSTOMER FEEDBACK: A SLIGHTLY CURVED, PERMANENT MINI-ANEURYSM CLIP (5 MM, REF.: 45.712) MANUFACTURED BY THE MEDICAL COMPANY ALEMKO IS REPORTED TO HAVE MALFUNCTIONED DURING USE IN A SURGICAL PROCEDURE ON PATIENT (B)(6). (THE CLIP IS PLACED ON THE DESIGNATED FORCEPS; THE SURGEON POSITIONS IT AND USES IT TO CLOSE THE ANEURYSM. AT THAT MOMENT, THE CLIP SPRINGS OPEN AND REMAINS OPEN, WHICH COULD HAVE LED TO A SEVERE ANEURYSM RUPTURE. IT IS REPLACED WITH ANOTHER CLIP, WHICH FUNCTIONS PROPERLY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831090 L-ANEURYSM-CLIP CLIP, ANEURYSM HCH PETER LAZIC GMBH 45.712

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown