BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PILLCAM SB2 CAPSULE

    MDR report key: 2483446 · Received March 4, 2012

    Report

    Report Number
    9710107-2012-00863
    Event Type
    Injury
    Date Received
    March 4, 2012
    Report Date
    February 29, 2012
    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

    ALTHOUGH THE PT HAD NO KNOWN HISTORY OF SWALLOWING PROBLEMS AND THE CAPSULE INGESTION WAS UNEVENTFUL, ONE MAY SUSPECT, HOWEVER, THAT THE PT DOES INDEED HAVE A SWALLOWING PROBLEM IF HE DID ASPIRATE THE CAPSULE WITHOUT ANY COUGHING OR GAGGING. SWALLOWING DISORDER IS A RECOGNIZED CONTRAINDICATION TO THE USE OF CAPSULE ENDOSCOPY.

    Description of Event or Problem · 1

    AN (B)(6) MALE WITH A HISTORY OF COPD (A CHRONIC LUNG DISEASE), WAS REFERRED TO A GI PHYSICIAN WITH A COUPLE OF EPISODES OF MELENA. THE PT ALSO STATED HE HAD LUNG CANCER AT THE TIME. HE HAD A NORMAL ENDOSCOPIC EXAM AND UGI SERIES. AFTER ANOTHER BLEED A CAPSULE STUDY WAS ORDERED. ACCORDING TO THE CUSTOMER, HE HAD THE PROCEDURE AND RETURNED THE EQUIPMENT, PRESUMABLY DOING OK. HE CLAIMS THAT THE VIDEO WAS NOT REVIEWED FOR 10 DAYS AND WHEN IT WAS DONE, THE PHYSICIAN SAW WHAT HE RECOGNIZED AS AIRWAY STRUCTURED, NOT INTESTINAL MUCOSA. THE PT WAS REFERRED TO A PULMONOLOGIST AND SUBSEQUENTLY HAD THREE UNSUCCESSFUL ATTEMPTS AT BRONCHOSCOPIC REMOVAL. ACCORDING TO THE CUSTOMER, THE CAPSULE REMAINED IN THE LUNG/AIRWAY. THE PT SUBSEQUENTLY "HAD A DECLINE AND WAS PUT IN A NURSING HOME", DYING 1.5 YEARS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PILLCAM SB2 CAPSULE PILLCAM SB CAPSULE NEZ GIVEN IMAGING LTD. PILLCAM SB2 CAPSULE NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R