BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PILLCAM PATENCY CAPSULE

    MDR report key: 2549498 · Received April 23, 2012

    Report

    Report Number
    9710107-2012-01373
    Event Type
    Injury
    Date Received
    April 23, 2012
    Report Date
    April 23, 2012
    Manufacturer
    GIVEN IMAGING LTD.
    Product Code
    NEZ
    PMA / PMN Number
    K053639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AGILE CAPSULE IS AN ACCESSORY TO THE PILLCAM VIDEO CAPSULE AND ITS INTENDED USE IS TO VERIFY ADEQUATE PATENCY OF THE GASTROINTESTINAL TRACT PRIOR TO ADMINISTRATION OF THE PILLCAM VIDEO CAPSULE IN PATIENTS WITH KNOWN OR SUSPECTED STRICTURES. THE PATIENT HAD A HISTORY OF SURGERY AND EXPECTED POST SURGICAL ADHESIONS. THE CAPSULE WAS PROBABLY RETAINED DUE TO ADHESIONS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OF A PATIENT THAT HAD A 42 HOUR RETENTION OF A PILLCAM PATENCY CAPSULE AND NEEDED MEDICAL INTERVENTION. THE PATIENT, WHO HAS A HISTORY OF SURGERY AND EXPECTED POST-SURGICAL ADHESIONS, WAS HOSPITALIZED AFTER COMPLAINING OF PAIN, NAUSEA AND VOMITING. ACCORDING TO THE CUSTOMER, THE PATIENT HAD INTERMITTENT OBSTRUCTIVE SYNDROME, PROBABLY FROM ADHESIONS. A CT SCAN SHOWED THE CAPSULE IS INTACT AND THE PATIENT EVENTUALLY WAS SENT TO SURGERY. THE CAPSULE WAS INTACT IN THE RESECTED BOWEL SEGMENT. IT IS POSSIBLE THAT THE PATIENT ALSO HAD CROHN'S DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PILLCAM PATENCY CAPSULE PILLCAM PATENCY CAPSULE NEZ GIVEN IMAGING LTD. PILLCAM PATENCY CAP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R