BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PNEUMOLINER

    MDR report key: 9564294 · Received January 8, 2020

    Report

    Report Number
    9616720-2019-00002
    Event Type
    Injury
    Date Received
    January 8, 2020
    Date of Event
    November 14, 2019
    Report Date
    January 8, 2020
    Manufacturer
    ADVANCED SURGICAL CONCEPTS LTD.
    Product Code
    PMU
    PMA / PMN Number
    DEN150028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUS VOLUNTARY EVENT REPORT (# MW5091187) WAS FILED IN THE MEDSUN DATABASE (FDA MAUDE).

    Description of Event or Problem · 1

    THE PNEUMOLINER BAG HAD BEEN DAMAGED DURING SURGERY BY GRASPING THE TISSUE SPECIMEN AND THE BAG AND ENGAGING THE POWER MORCELLATOR. THE SURGICAL TECHNICIAN NOTICED AND THE PROCEDURE WAS STOPPED. THE SURGEON CONFIRMED THERE WAS NO VISCERA DAMAGE AND IT WAS ONLY THE PNEUMOLINER BAG THAT HAD BEEN BREACHED. SOME PIECES OF THE FIBROID TISSUE SPILLED INTO THE ABDOMINAL CAVITY. THESE WERE PICKED OUT; NO FRAGMENTS WERE LEFT IN THE PATIENT. THE SURGICAL TECHNICIAN NOTICED A SMALL PIECE OF THE BAG WAS MISSING. THE SURGICAL TEAM DID EVERYTHING THEY COULD TO LOCATE THE SMALL PIECE OF BAG MATERIAL. THEY FLUSHED THE ABDOMINAL CAVITY WITH 2L OF SALINE. THEY FLUSHED SALINE THROUGH THE LENA MORCELLATOR AND THEY EXAMINED THE MORCELLATED TISSUE BUT WERE UNABLE TO LOCATE THE MISSING PIECE OF THE BAG. THEY ALSO PERFORMED AN X-RAY ON THE PATIENT AS THIS WAS HOSPITAL PROTOCOL. THIS REPORT IS BEING RAISED AS A PATIENT INJURY DUE TO THE UNKNOWN LOCATION OF THE SPECIMEN BAG FRAGMENT AND THE POSSIBILITY THAT IT REMAINED IN THE PATIENT. ALTHOUGH IT IS UNLIKELY WHETHER SUCH AN EVENT RESULTING IN A SMALL PIECE OF POLYURETHANE MATERIAL, WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF IT WERE TO RECUR, ASC IS FILING THIS MEDWATCH REPORT OUT OF AN ABUNDANCE OF CAUTION TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803. THE PATHOLOGY REPORT SHOWS THE PATIENT WAS CANCER FREE. THERE WAS NO INJURY TO THE PATIENT FROM USE OF THE DEVICE. THE PATIENT REPORTED NO ADVERSE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29122 PNEUMOLINER LAPAROSCOPIC POWER MORCELLATION CONTAINMENT SYSTEM PMU ADVANCED SURGICAL CONCEPTS LTD. WA90500US 113202

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization