BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORBERA INTRAGASTRIC BALLOON SYSTEM

    MDR report key: 6223714 · Received January 4, 2017

    Report

    Report Number
    3006722112-2017-00006
    Event Type
    Injury
    Date Received
    January 4, 2017
    Report Date
    December 6, 2016
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    LTI
    UDI-DI
    10811955020619
    PMA / PMN Number
    P140008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER OF THE EVENT WAS ASKED TO PROVIDE PRODUCT SERIAL NUMBER. TO DATE, APOLLO HAS NOT RECEIVED THE DEVICE INFORMATION. DEVICE LABELING ADDRESSES THE REPORTED EVENT AS FOLLOWS: POSSIBLE COMPLICATIONS OF ROUTINE ENDOSCOPY & SEDATION: POTENTIAL RISKS ASSOCIATED WITH UPPER ENDOSCOPIC PROCEDURES INCLUDE, BUT ARE NOT LIMITED TO: ABDOMINAL CRAMPING AND DISCOMFORT FROM THE AIR USED TO DISTEND THE STOMACH, SORE OR IRRITATED THROAT, BLEEDING, INFECTION, TEARING OF THE ESOPHAGUS OR STOMACH, AND ASPIRATION PNEUMONIA. THE RISK INCREASES IF ADDITIONAL PROCEDURES ARE PERFORMED. WARNINGS: ENDOSCOPIC REMOVAL OF ORBERA MUST BE COMPLETED IN THE PRESENCE OF AN EMPTY STOMACH. PATIENTS SHOULD BE NPO FOR A MINIMUM OF 12 HOURS PRIOR TO REMOVAL. IF FOOD IS FOUND IN THE STOMACH UPON ENDOSCOPIC EXAMINATION, THEN MEASURES (ASPIRATION OF STOMACH CONTENTS, ENDOTRACHEAL INTUBATION, OR DELAY OF PROCEDURE) MUST BE TAKEN TO PROTECT THE AIRWAY. THE RISK OF ASPIRATION OF GASTRIC CONTENTS INTO THE PATIENT'S LUNGS REPRESENTS A SERIOUS RISK WHICH CAN RESULT IN DEATH.

    Description of Event or Problem · 1

    REPORT AS: A PATIENT WITH THE ORBERA INTRAGASTRIC BALLOON "DID NOT DISCLOSE TO THE ANESTHESIOLOGIST PRIOR TO A KNEE REPLACEMENT THAT THEY HAD AN INTRAGASTRIC BALLOON. PATIENT WAS PUT ON "NORMAL" NPO FOR 12 HOURS PRIOR TO KNEE SURGERY. PATIENT ASPIRATED DUE TO STOMACH NOT BEING EMPTY". DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5518 ORBERA INTRAGASTRIC BALLOON SYSTEM INTRAGASTRIC BALLOON LTI APOLLO ENDOSURGERY, INC. B-4800 NI 10811955020619

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention