BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-CLIP STANDARD/MINI ANLEGEZANGE

    MDR report key: 19069584 · Received April 9, 2024

    Report

    Report Number
    8010890-2023-00002
    Event Type
    Malfunction
    Date Received
    April 9, 2024
    Date of Event
    August 21, 2023
    Report Date
    August 4, 2024
    Manufacturer
    PETER LAZIC GMBH MICROSURGICAL INNOVATIONS
    Product Code
    HCI
    UDI-DI
    04250603739609
    Removal / Correction Number
    93938
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE INCIDENT OCCURED IN ECUADOR. OUR DISTRIBUTOR IN ECUADOR HAS RECEIVED THE FOLLOWING INFORMATION FROM HIS CUSTOMER: THE APPLIER FAILED DURING SURGERY. THE APPLIER DID NOT RELEASE THE CLIP. THE APPLIER REMAINED ATTACHED TO THE CLIP. THE AFFECTED APPLIER AND ALL SIMILAR APPLIERS WITH THE ARTICLE NUMBERS 35.410, 35.411 AND 35.412 ARE BEING REMOVED FROM THE MARKET. THESE ARE ALL APPLIERS WITH A RIGID JAW. IT IS PLANNED TO REDESIGN THE JAW PART OF THE APPLIER TO PREVENT THE DEFECT FROM RECURRING AS FAR AS POSSIBLE. TO THIS END, PROTOTYPES WERE PRODUCED AND GIVEN TO VARIOUS DOCTORS IN ORDER TO OBTAIN FEEDBACK ON THE REDESIGN OF THE JAW PARTS. THE PATIENT WAS NOT INJURED. HOWEVER, THE INCIDENT COULD HAVE LED TO A DETERIORATION OF THE HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2309918 D-CLIP STANDARD/MINI ANLEGEZANGE APPLIER, ANEURYSM CLIP HCI PETER LAZIC GMBH MICROSURGICAL INNOVATIONS 35.411 W591456 04250603739609

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown