BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AL-LI-GATOR

    MDR report key: 10253583 · Received July 9, 2020

    Report

    Report Number
    3002590791-2020-00036
    Event Type
    Injury
    Date Received
    July 9, 2020
    Date of Event
    March 21, 2018
    Report Date
    July 9, 2020
    Manufacturer
    GENICON, INC.
    Product Code
    FZP
    UDI-DI
    00877972004554
    PMA / PMN Number
    K100090
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTABLE INJURY WAS IDENTIFIED DURING A REVIEW OF COMPLAINTS RECEIVED BETWEEN OCTOBER 2017 AND DECEMBER 2019. THROUGH REVIEW AND COMMUNICATION FROM THE SURGEON, THE LIKELY CAUSE IS THAT A LARGER CLIP SHOULD HAVE BEEN USED ON THE VESSEL. THE TWO SUSPECT CLIP APPLIERS WERE RETURNED TO GENICON, AND FOUND TO FUNCTION NORMALLY; THERE WERE MISALIGNMENTS OR OTHER ISSUES PRESENT.

    Description of Event or Problem · 1

    DISTRIBUTOR HAS RECEIVED COMPLAINTS FROM THEIR CUSTOMERS THAT CLIPS, PART NUMBER 350-000-103 AND LOT NUMBER 026214, WHICH THEY PURCHASED IN (B)(6) (2018) AREN'T SAFE BECAUSE THEY TORN AND MAKE TRAUMAS IN ARTERIES AND BILE DUCTS. THEY CAUSED A LOT OF BLEEDINGS INSIDE THE BODY. CUSTOMER BELIEVES THE CLIP APPLIER IS EITHER PART NUMBER 350-010-002, LOT NUMBER 07161229 OR LOT NUMBER 07161230.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719393 AL-LI-GATOR IMPLANTABLE CLIP FZP GENICON, INC. 350-000-103 026214 00877972004554

    Patients

    Seq Age Sex Outcome Treatment
    1 Other