BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PILLCAM SB2 CAPSULE

    MDR report key: 3904179 · Received May 27, 2014

    Report

    Report Number
    9710107-2014-00116
    Event Type
    Injury
    Date Received
    May 27, 2014
    Report Date
    April 28, 2014
    Manufacturer
    GIVEN IMAGING LTD.
    Product Code
    NEZ
    PMA / PMN Number
    K101250
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CASE REPORT OF A POTENTIAL COMPLICATION OF VIDEO CAPSULE ENDOSCOPY. A (B)(6)-YEAR-OLD MAN PRESENTED TO OUR EMERGENCY ROOM WITH MALENA AND SYMPTOMS SUGGESTIVE OF ANAEMIA. HE WAS ON CHRONIC ANTICOAGULATION WITH WARFARIN FOR A MECHANICAL AORTIC VALVE. HE WAS HAEMODYNAMICALLY STABLE. LABORATORY INVESTIGATIONS REVEALED A LOW HAEMOGLOBIN LEVEL OF 7.1 G/DL AND A LOW-FERRITIN LEVEL OF 6 NG/DL SUGGESTING CHRONIC GASTROINTESTINAL BLEEDING. OESOPHAGOGASTRODUODENDOSCOPY AND COLONOSCOPY WERE PERFORMED TO IDENTIFY THE SOURCE OF BLEEDING BUT WERE UNFRUITFUL. VIDEO CAPSULE ENDOSCOPY WAS PERFORMED. FIFTEEN HOUSE AFTER INGESTING THE CAPSULE ENDOSCOPE, THE PATIENT STARTED HAVING SEVERE ABDOMINAL PAIN, NAUSEA AND VOMITING. ABDOMINAL X-RAY DID NOT SHOW ANY BOWEL PERFORATION. CT OF THE ABDOMEN REVEALED IMPACTION OF THE CAPSULE ENDOSCOPE AT THE APPENDICEAL ORIFICE AND AN INFLAMED APPENDIX. PATIENT UNDERWENT LAPAROSCOPIC APPENDECTOMY AND MADE A GOOD RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311746 PILLCAM SB2 CAPSULE PILLCAM SB2 CAPSULE NEZ GIVEN IMAGING LTD. PILLCAM SB2 CAPSULE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention