BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MULTIPLE CLIP APPLIER

    MDR report key: 153511 · Received February 26, 1998

    Report

    Report Number
    1527736-1998-00536
    Event Type
    Malfunction
    Date Received
    February 26, 1998
    Date of Event
    January 15, 1998
    Report Date
    January 29, 1998
    Manufacturer
    LACEY MANUFACTURING CO.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING #.49096. EES#.980682/LACEY. D5,6;H4: INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS USED DURING A PROSTATECTOMY PROCEDURE. IT WAS REPORTED THE MCL20 CLIPS WERE SCISSORING AND WOULD NOT HOLD THE TISSUE. IT WAS REPORTED THE PROCEDURE WAS COMPLETED WITH A SINGLE REUSABLE CLIP APPLIER. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other