BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MULTIPLE CLIP APPLIER

    MDR report key: 42891 · Received October 2, 1996

    Report

    Report Number
    1218017-1996-00010
    Event Type
    Malfunction
    Date Received
    October 2, 1996
    Date of Event
    August 19, 1996
    Report Date
    October 2, 1996
    Manufacturer
    LACEY MFG CO.
    Product Code
    FZP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A1,2,3,4;B6,7;D10: INFO UNAVAILABLE: 9/4/96 1515 MESSAGE AND 800# LEFT FOR MD CALL BACK. 9/5/96 SURGEON RETURNED CALL. HE STATED THE CLIPS FROM THE MCM AND MCS SCISSORED AND CUT THE VESSEL IN HALF. HE STATED ON ONE INSTRUMENT 1 0R 2 IN A ROW DID THIS AND ON THE OTHER 2 OR 3 DID. HE STATED HE WAS ABLE TO COMPLETE THE CASE WITH THESE INSTRUMENTS. "GOOD" CLIPS FROM THESE APPLIERS WERE USED TO CONTROL THE BLEEDING. D5,6;H4: INFO UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A PLASTIC NECK RECONSTRUCTION. IT WAS REPORTED THE MCM AND CLIPS SPIT FROM THE APPLIER. THE APPLIER WAS CLOSED ON A VESSEL WITHOUT CLIP IN THE JAWS AND CUT THE VESSEL. THE SURGEON TIED THE VESSEL WITH SUTURE TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP MULTIPLE CLIP APPLIER CLIP APPLIER FZP LACEY MFG CO. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other