BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 332464 · Received May 3, 2001

    Report

    Report Number
    1527736-2001-02313
    Event Type
    Malfunction
    Date Received
    May 3, 2001
    Date of Event
    March 6, 2001
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED WITH A USER FACILITY MEDWATCH #362-330-2001-02 THAT THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE CLIP APPLIER MISFIRED DURING PROCEDURE, NOT APPLYING CLIPS. UNKNOWN HOW THE CASE WAS COMPLETED. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20801 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER CLIP APPLIER-ENDOSCOPIC GDO ETHICON ENDO-SURGERY, INC. NA M4FU27

    Patients

    Seq Age Sex Outcome Treatment
    1 Other