BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ROTATING MULTIPLE-CLIP APPLIER

    MDR report key: 3001300 · Received March 4, 2013

    Report

    Report Number
    3001300
    Event Type
    Malfunction
    Date Received
    March 4, 2013
    Date of Event
    December 15, 2012
    Report Date
    March 4, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE OPERATIVE PROCEDURE, THE CLIP APPLICATION FAILED. THIS REQUIRED ANOTHER DEVICE TO BE BROUGHT TO THE FIELD FOR USE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAPAROSCOPIC CHOLECYSTECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91495 LIGACLIP ROTATING MULTIPLE-CLIP APPLIER APPLIER, SURGICAL, CLIP GDO ETHICON ENDO-SURGERY, INC. A94211P00 *

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR