BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIGACLIP MULTIPLE CLIP APPLIER

    MDR report key: 288531 · Received August 4, 2000

    Report

    Report Number
    1527736-2000-03553
    Event Type
    Death
    Date Received
    August 4, 2000
    Date of Event
    February 28, 2000
    Report Date
    July 10, 2000
    Manufacturer
    LACEY MFG CO.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP (1) MCM20 WAS USED DURING A SIGMOID RESECTION PROCEDURE. IT WAS REPORTED BY THE REP THAT IN 2000, THE PT WAS PRESENTED WITH AN OBSTRUCTED SIGMOID MASS. A SIGMOID RESECTION WAS PERFORMED. FOUR DAYS LATER, THE PT WAS RETURNED WITH ACUTE ABDOMINAL PAIN AND POSTOPERATIVE DIAGNOSIS WITH BREAKDOWN OF BOWEL AT ANASTOMOTIC SITE. THE PT RETURNED A THIRD TIME WITH BREAKDOWN AT BOWEL ANASTOMOTIC SITE. THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP MULTIPLE CLIP APPLIER CLIP APPLIER GDO LACEY MFG CO. NA M4F44X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death| O