BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PILLCAM SB2

    MDR report key: 1398923 · Received May 11, 2009

    Report

    Report Number
    9710107-2009-00082
    Event Type
    Injury
    Date Received
    May 11, 2009
    Date of Event
    April 13, 2009
    Manufacturer
    GIVEN IMAGING LTD.
    Product Code
    NEZ
    PMA / PMN Number
    K070475
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    GIVEN IMAGING CHIEF MEDICAL OFFICER HAS DISCUSSED WITH THE PT PHYSICIAN AND SENT HIM TWO CASE REPORTS FOR HIS REFERENCE. THIS PT ATTEMPTED TO SWALLOW THE CAPSULE, BUT CHOCKED AND ASPIRATED THE CAPSULE INSTEAD, AND REQUIRED BRONCHOSCOPY. THIS SUGGESTS THAT THE PT DID HAVE A SWALLOWING DISORDER, WHICH IS A RECOGNIZED CONTRAINDICATION TO THE USER OF CAPSULE ENDOSCOPY. THIS WOULD INDICATE A USER ERROR.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ON THE FOLLOWING INCIDENT, THE PT, A MALE, WHO ASPIRATED THE CAPSULE AFTER CHOKING TRYING TO SWALLOW IT. IT HAS BEEN LOCALIZED AT THE R MEDIAL BASAL SEGMENT OF THE LOWER LOBE BRONCHUS. THE CAPSULE HAD BEEN STUCK IN THE LUNGS FOR TWO WEEKS. ATTEMPTS TO REMOVE THIS FIRST BY FLEXIBLE BRONCHOSCOPY, THEN BY RIGID BRONCHOSCOPY WITH A CAPTURE NET HAVE BEEN UNSUCCESSFUL. THE PT IS CURRENTLY AT HOME AND IN NO APPARENT SIGNIFICANT DISTRESS. THE PT PHYSICIAN WANTED TO KNOW WHAT TYPE OF MEDICAL DEVICE SHOULD BE USED TO REMOVE THE CAPSULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PILLCAM SB2 PILLCAM SB2 NEZ GIVEN IMAGING LTD. SB2

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention