BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    PNEUMOLINER

    MDR report key: 18291170 · Received December 8, 2023

    Report

    Report Number
    9616720-2023-00001
    Event Type
    Injury
    Date Received
    December 8, 2023
    Date of Event
    October 10, 2023
    Report Date
    December 8, 2023
    Manufacturer
    ADVANCED SURGICAL CONCEPTS LTD
    Product Code
    PMU
    PMA / PMN Number
    K192898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MW5146964 DETAILED INSUFFICIENT AND CONTRADICTORY INFORMATION WHICH DID NOT ALLOW IDENTIFICATION OF THE DEVICE OR WHAT, IF ANY, INJURY OCCURRED. THE SUSPECT DEVICE DESCRIPTION AND PRO-CODE DID NOT MATCH. FURTHERMORE, THE PHYSICIAN NAME AND INSTITUTION IS NOT PROVIDED WHICH PREVENTED INVESTIGATION. SHOULD NEW INFORMATION BECOME AVAILABLE A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    MW5146964 WAS RECEIVED ON 11.15.2023. THE REPORT STATES THE FOLLOWING: "OLYMPUS GARDENIA UTERINE MORCELLATION SYSTEM BAG RIPPED DURING MORCELLATION PROCESS. NO INJURY TO UNDERLYING BOWEL OR OTHER ORGANS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222540 PNEUMOLINER LAPAROSCOPIC POWER MORCELLATION CONTAINMENT SYSTEM PMU ADVANCED SURGICAL CONCEPTS LTD WA90500US

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization