BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROLINE SURGICAL

    MDR report key: 4317276 · Received December 4, 2014

    Report

    Report Number
    MW5039418
    Event Type
    Injury
    Date Received
    December 4, 2014
    Date of Event
    November 8, 2014
    Report Date
    December 4, 2014
    Manufacturer
    MICROLINE SURGICAL
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A (B)(6) PREGNANT FEMALE WITH IUP HAD AN OPEN CHOLECYSTECTOMY THE REUSABLE CLIP APPLIER MISFIRED AND THE CLIPS FELL OFF THE CYSTIC ARTERY CAUSING A BLEED OF ABOUT 200CC. THE CLIPS DID NOT SECURE TO THE ARTERY. THE SURGEON LIGATED THE DUCT WITH SUTURE AND WHEN ANOTHER CLIP APPLIER WAS OBTAINED, USED THOSE CLIPS. THE CASE WAS DELAYED DUE TO EQUIPMENT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782838 MICROLINE SURGICAL 19 CLIP CARTRIDGE GDO MICROLINE SURGICAL 1112 00118432

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Life Threatening| R