BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MULTIPLE CLIP APPLIER

    MDR report key: 84987 · Received April 15, 1997

    Report

    Report Number
    1218017-1997-00031
    Event Type
    Malfunction
    Date Received
    April 15, 1997
    Date of Event
    January 3, 1997
    Report Date
    April 7, 1997
    Manufacturer
    LACEY MANUFACTURING COMPANY, INC.
    Product Code
    FZP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICES WERE USED DURING A NEPHRECTOMY PROCEDURE. IT WAS REPORTED THE CLIPS FROM FOUR MCL20 DEVICES WOULD ONLY FORM PROXIMALLY CREATING AN "OVAL" SHAPED CLIP. THIS RESULTED IN LITTLE HEMOSTASIS. THERE WAS NO CONSEQUENCE TO THE PT. 1/7/97 1145 IT WAS REPORTED THE SURGEON COMPLETED THE PROCEDURE BY USING A MCM20 AND SUTURE TO ACHIEVE HEMOSTASIS. 1/7/97 1045 ATTEMPTED TO REACH THE SURGEON. NUMBER WOULD NOT DIAL. WILL TRY AT A LATER TIME. 1/7/97 1300 LEFT MESSAGE AND 800# FOR MD TO CALL BACK. 1/8/97 1030 NNCL SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP MULTIPLE CLIP APPLIER CLIP APPLIER FZP LACEY MANUFACTURING COMPANY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other