BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AER-O-SCOPE DISPOSABLE COLONOSCOPE SYSTEM

    MDR report key: 18918938 · Received March 16, 2024

    Report

    Report Number
    3010229237-2024-00002
    Event Type
    Injury
    Date Received
    March 16, 2024
    Date of Event
    February 14, 2024
    Report Date
    February 22, 2024
    Manufacturer
    GI VIEW LTD.
    Product Code
    FDF
    PMA / PMN Number
    K230588N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE ADVERSE EVENT IS A KNOWN RARE (1:10,000) COMPLICATION OF COLONOSCOPY, IT IS INCONCLUSIVE IF THE EVENT WAS DEVICE RELATED OR PROCEURE RELATED.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT A FULL COLONOSCOPY WITH THE AER-O-SCOPE DISPOSABLE COLONOSCOPE. TWO (2) DAYS POST PROCEDURE, THE PATIENT CONTACTED THE HEALTH PROVIDER COMPLAINING OF PAIN. THE PATIENT WAS ADMITTED INTO THE HOSPITAL WITH A STAGE 4 SPLENIC LACERATION AND WAS TREATED CONSERVATIVELY. THE PATIENT WAS RELEASED FOLLOWING ONE (1) WEEK IN THE HOSPITAL. SPLENIC LACERATION IS A KNOWN RARE COMPLICATION (1:10,000) OF COLONOSCOPY. AS SUCH, THE CAUSE OF THE ADVERSE EVENT IS INCONCLUSIVE AS TO WHETHER IT WAS DEVICE RELATED OR PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186078 AER-O-SCOPE DISPOSABLE COLONOSCOPE SYSTEM COLONOSCOPE FDF GI VIEW LTD. MASA2800 4011201

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Life Threatening| H