BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PILLCAM SB2

    MDR report key: 1245925 · Received November 24, 2008

    Report

    Report Number
    9710107-2008-00004
    Event Type
    Injury
    Date Received
    November 24, 2008
    Date of Event
    October 20, 2008
    Report Date
    November 24, 2008
    Manufacturer
    GIVEN IMAGING LTD.
    Product Code
    NEZ
    PMA / PMN Number
    K070475
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING GIVEN IMAGING MEDICAL ADVISOR FOLLOW-UP CONVERSATION WITH DR, IT WAS REVEALED THE PT HAS BEEN DISCHARGED FROM THE HOSPITAL, HAS SHORT BOWEL SYNDROME DUE TO THE EXTENSIVE BOWEL RESECTION AND ON DIALYSIS. THERE HAVE BEEN NO FURTHER DEVELOPMENTS IN UNDERSTANDING WHAT LED TO HIS RAPID DETERIORATION AFTER CAPSULE INGESTION. THE PATHOLOGY FROM THE BOWEL RESECTION SHOWED NECROTIC BOWEL THAT WAS NOT HELPFUL IN DETERMINING THE ETIOLOGY OF THIS DISEASE. THE PT HAD HAD TWO PRIOR EPISODES OF BOWEL OBSTRUCTION, UNRELATED TO CAPSULE ENDOSCOPY, AND HE WAS REPORTED TO HAVE PARTIAL INTESTINAL MALROTATION. THUS, THE PT MAY HAVE BEEN PREDISPOSED TO DEVELOP BOWEL OBSTRUCTION. IT IS UNCLEAR WHAT MAY HAVE PRECIPITATED THE MOST RECENT EPISODE OF BOWEL OBSTRUCTION. THE TREATMENT PHYSICIANS DO NOT KNOW IF THE PILLCAM CAPSULE PLAYED A ROLE IN THIS EVENT. THE CAPSULE DID FUNCTION AS DESIGNED AND THE CAPSULE WAS EXCRETED INTACT. ADMINISTRATION OF PILLCAM SB2 IN PTS WITH KNOWN OR SUSPECTED STRICTURES IS CONTRAINDICATED. THIS EVENT IS NOT RELATED TO ANY MALFUNCTION OR PROBLEM WITH THE DEVICE.

    Description of Event or Problem · 1

    A MALE, UNDERWENT CAPSULE ENDOSCOPE FOR INVESTIGATION OF WEIGHT LOSS WITH CHRONIC DIARRHEA. CAPSULE ENDOSCOPE PROCEDURE HAS STARTED AT 8 AM. PT CAME BACK TO THE OFFICE FOR THE REMOVAL OF DATARECORDER AND STUDY DOWNLOAD. THERE WAS NO CHANGE IN HIS HEALTH STATUS UNTIL THE EVENING ON THE SAME DAY OF INGESTION WHEN HE BECAME ACUTELY ILL AND RAPIDLY DECOMPENSATED IN THE EMERGENCY ROOM. AT APPROX 8 PM, PT WAS ADMITTED TO EMERGENCY PRESENTING WITH SEVERE DISTRESS. HE DEVELOPED HYPOTENSION, SEPSIS, DIC AND REMAINED IN INTENSIVE CARE. HE WAS BELIEVED TO HAVE INTESTINAL VOLVULUS AND ACUTE BOWEL OBSTRUCTION. THE PT UNDERWENT EMERGENCY SURGERY TWICE, RESULTING IN RESECTION OF FOUR METERS OF SMALL BOWEL. THE CAPSULE REMAINS IN THE LEFT UPPER QUADRANT OF THE ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PILLCAM SB2 NONE NEZ GIVEN IMAGING LTD. PCSB-2-X-S 5966S2S

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| L