BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PNEUMOLINER

    MDR report key: 8771649 · Received July 9, 2019

    Report

    Report Number
    9616720-2019-00001
    Event Type
    Injury
    Date Received
    July 9, 2019
    Date of Event
    June 12, 2019
    Report Date
    July 9, 2019
    Manufacturer
    ADVANCED SURGICAL CONCEPTS LTD.
    Product Code
    PMU
    PMA / PMN Number
    DEN150028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A ZERO-DEGREE SCOPE WAS USED FOR VISION INSIDE THE BAG CONTRARY TO THE VALIDATED TRAINING AND IFU WHICH STATES A MINIMUM OF 30 DEGREE SCOPE IS REQUIRED TO GIVE AN ADEQUATE FIELD OF VISION. AN UNTRAINED RESIDENT WAS ACTUATING THE TENACULUM. THE TRAINING AND IFU STIPULATES THAT ONLY A PHYSICIAN WHO HAS COMPLETED THE VALIDATED PNEUMOLINER TRAINING MAY PERFORM THE CONTAINED MORCELLATION PROCEDURE.

    Description of Event or Problem · 1

    WHILE PERFORMING THE CONTAINED POWER MORCELLATION THE PNEUMOLINER BAG WAS PUNCTURED AND A SECTION OF SMALL BOWEL WAS MORCELLATED. THE PHYSICIAN GRASPED THE PNEUMOLINER BAG WITH THE TENACULUM AND PROCEEDED TO ENGAGE THE POWER MORCELLATOR AND MORCELLATED A SECTION OF THE PNEUMOLINER BAG AND A SECTION OF SMALL BOWEL. THE PATIENT UNDERWENT END TO END ANASTOMOSIS WITH APPROXIMATELY 20 CM OF BOWEL RESECTED. THE PATIENT HAS LEFT HOSPITAL AFTER A RETURN TO NORMAL BOWEL FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564760 PNEUMOLINER LAPAROSCOPIC POWER MORCELLATION CONTAINMENT SYSTEM PMU ADVANCED SURGICAL CONCEPTS LTD. WA90500US 113202

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R