BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PILLCAM SB CAPSULE

    MDR report key: 1742202 · Received June 18, 2010

    Report

    Report Number
    9710107-2010-00400
    Event Type
    Injury
    Date Received
    June 18, 2010
    Report Date
    June 22, 2010
    Manufacturer
    GIVEN IMAGING LTD.
    Product Code
    NEZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT HAS BEEN PUBLISHED IN GUT AND LIVER, VOL. 4, NO. 1, MARCH 2010, PP 114-116, A CASE OF ASYMPTOMATIC ASPIRATION OF A CAPSULE ENDOSCOPE WITH A SUCCESSFUL RESOLUTION. THE INVESTIGATORS CONCLUDED THAT: "IN CONCLUSION, THE ASPIRATION OF A CAPSULE ENDOSCOPE IS A RARE BUT IMPORTANT COMPLICATION THAT MAY PROGRESS TO HYPOXIC SHOCK AND CHRONIC LUNG DISEASE. A CAREFUL HISTORY AND ENDOSCOPIC INSERTION OF THE CAPSULE IN HIGH-RISK PTS CAN PREVENT PULMONARY ASPIRATION OF THE CAPSULE. IF THE CAPSULE IS ASPIRATED INTO THE BRONCHUS, INDUCING THE PT TO COUGH MAY FACILITATE BRONCHOSCOPIC REMOVAL USING A NET."

    Description of Event or Problem · 1

    THE FOLLOWING IS A SUMMARY OF THE EVENT FROM THE PUBLICATION: A (B)(6), MAN, WAS REFERRED FOR CAPSULE ENDOSCOPY TO EVALUATE SMALL BOWEL BLEEDING. GASTROSCOPY, COLONOSCOPY, AND COMPUTED TOMOGRAPHY (CT) OF THE ABDOMEN WITH CONTRAST PERFORMED AT ANOTHER HOSPITAL HAD NOT REVEALED A SOURCE OF THE BLEEDING. ALTHOUGH HE HAD EXPERIENCED A CEREBROVASCULAR ACCIDENT 5 YEARS EARLIER, HE HAD NO DIFFICULTY IN SWALLOWING PRIOR TO ADMISSION. THE PT SWALLOWED THE CAPSULE IN THE PRESENCE OF A DOCTOR, COUGHING SEVERAL TIMES. SUBSEQUENTLY, HE DID NOT COMPLAIN OF ANY DYSPHAGIA OR RESPIRATORY SYMPTOMS. A PLAIN ABDOMINAL X-RAY WAS TAKEN 2 HOURS LATER TO CONFIRM THE CAPSULE POSITION, BUT THE CAPSULE WAS NOT SEEN. WE, THEREFORE, TOOK A CHEST X-RAY TO LOCATE THE CAPSULE AND THE CAPSULE WAS FOUND IN THE LEFT CHEST. WE PERFORMED AN IMMEDIATE BRONCHOSCOPY TO CONFIRM PULMONARY ASPIRATION OF THE CAPSULE. THE CAPSULE WAS IMPACTED TIGHTLY IN THE LEFT MAIN BRONCHUS. WE WERE FINALLY ABLE TO GRASP THE CAPSULE AND REMOVE IT SUCCESSFULLY. SUBSEQUENTLY, IT WAS RECOMMENDED THAT THE PT UNDERGO A VIDEOFLUOROSCOPY TO EVALUATE THE SWALLOWING MECHANISM BUT THE PT REFUSED TO UNDERGO THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PILLCAM SB CAPSULE PILLCAM SB CAPSULE NEZ GIVEN IMAGING LTD. NOT AVAILABLE NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention