BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APLIER

    MDR report key: 295260 · Received September 12, 2000

    Report

    Report Number
    1527736-2000-04295
    Event Type
    Death
    Date Received
    September 12, 2000
    Date of Event
    August 18, 2000
    Report Date
    August 19, 2000
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THAT THE ONE ER320 WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. IT WAS REPORTED THAT A CLIP FELL OFF OF THE PT POST-OP AND RESULTED IN A BILE DUCT LEAK. 8/23/2000 REP RESPONDED THAT THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APLIER CLIP APPLIER GDO ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death