BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS PNEUMOLINER CONTAINED DEVICE

    MDR report key: 9348814 · Received November 19, 2019

    Report

    Report Number
    MW5091187
    Event Type
    Injury
    Date Received
    November 19, 2019
    Date of Event
    November 13, 2019
    Report Date
    November 18, 2019
    Manufacturer
    ADVANCED SURGICAL CONCEPTS (ASC)
    Product Code
    PMU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A ROBOTIC ASSISTED LAPAROSCOPIC MYOMECTOMY, BILATERAL SALPINGO-OOPHORECTOMY A LINA MORCELLATOR AND AN OLYMPUS CONTAINED EXTRACTION SYSTEM WAS USED FOR REMOVING THE FIBROIDS FROM THE ABDOMEN. THE VENDOR REP PROVIDED THE OLYMPUS CONTAINED EXTRACTION SYSTEM FROM HIS STOCK. DURING THE PROCEDURE IT WAS NOTED THAT THE EXTRACTION SYSTEM LINER HAD A HOLE IN IT FROM THE MORCELLATOR CUTTING THE BAG WITH THE FIBROID TISSUE. THE BAG WAS INSPECTED AND APPEARED TO HAVE A SMALL 1-2 MM PIECE MISSING. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1137253 OLYMPUS PNEUMOLINER CONTAINED DEVICE CONTAINMENT SYSTEM, LAPAROSCOPIC POWER MORCELLATION WITH INSTRUMENT PORT PMU ADVANCED SURGICAL CONCEPTS (ASC) WA90500US 113202

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention