BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP 20/20 MULTIPLE CLIP APPLIER

    MDR report key: 217951 · Received April 6, 1999

    Report

    Report Number
    1527736-1999-01971
    Event Type
    Malfunction
    Date Received
    April 6, 1999
    Date of Event
    February 27, 1999
    Report Date
    March 13, 1999
    Manufacturer
    LACEY MANUFACTURING CO.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (3) DEVICES WERE USED DURING A ADRENALECTOMY. IT WAS REPORTED BY THE AFFILIATE THAT THE TIM20 WAS SLOW AT FIRING WHEN USED. THIS CAUSED SCISSORING OF VESSEL INSTEAD OF APPLYING CLIP. THIS LED TO THE OPENING OF TWO MORE DEVICES WHICH ALSO HAD THE SAME PROBLEM. FINALLY, THE FOURTH DEVICE WORKED FINE TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP 20/20 MULTIPLE CLIP APPLIER CLIP APPLIER GDO LACEY MANUFACTURING CO. NA L4CY9J

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other