BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PILLCAM

    MDR report key: 7929717 · Received October 3, 2018

    Report

    Report Number
    9710107-2018-00971
    Event Type
    Injury
    Date Received
    October 3, 2018
    Date of Event
    August 14, 2018
    Report Date
    October 3, 2018
    Manufacturer
    GIVEN IMAGING LTD., YOQNEAM
    Product Code
    NEZ
    UDI-DI
    07290101364399
    PMA / PMN Number
    K123864
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE PATIENT COMPLAINED OF COUGHING A LOT AND THAT THE CAPSULE FELT STUCK AFTER INGESTING IT. THE CUSTOMER INFORMED THAT THE RECORDER WAS FLASHING YELLOW AND WENT TO ADAPTIVE FREQUENCY RESPONSE TO AN EXCLAMATION MARK. TECHNICAL SUPPORT INFORMED THE CUSTOMER THAT SINCE THE RECORDER WAS FLASHING YELLOW FOR 20-30 MINUTES, THE UNIT WENT INTO END OF PROCEDURE MODE AND HAD STOPPED RECORDING. AS PER THE CUSTOMER, THEY PERFORMED AN ESOPHAGEAL GASTRODUODENOSCOPY AND DID NOT SEE THE CAPSULE, SO THEY WILL HAVE THE PATIENT TAKE X-RAYS TO CONFIRM IF THE CAPSULE WAS PASSED BEFORE HAVING THE PATIENT INGEST A SECOND CAPSULE. TECH SUPPORT INFORMED THE CUSTOMER TO CREATE THE VIDEO AND RECHECK IN THE PATIENT TO SEE IF THEY CAN RESUME RECORDING. THE X-RAY FINDINGS SHOWED THAT THE CAPSULE WAS IN THE RIGHT BRONCHUS. THERE WAS NO REPORTED PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773096 PILLCAM SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE NEZ GIVEN IMAGING LTD., YOQNEAM FGS-0501 07290101364399

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention