BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PILLCAM SB2 CAPSULE

    MDR report key: 2632400 · Received June 21, 2012

    Report

    Report Number
    9710107-2012-01476
    Event Type
    Injury
    Date Received
    June 21, 2012
    Report Date
    June 21, 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

    GIVEN IMAGING LABELING, SUCH AS USER MANUAL INDICATES THAT PILLCAM SB CAPSULES ARE CONTRAINDICATED FOR USE IN PATIENTS WITH KNOWN OR SUSPECTED GASTROINTESTINAL OBSTRUCTION, STRICTURES, OR FISTULAS BASED ON THE CLINICAL PICTURE OR PRE PROCEDURE TESTING AND PROFILE. DIAGNOSTIC TOOLS ARE AVAILABLE TO PHYSICIANS TO ASSESS PATIENTS BEFORE ADMINISTRATION OF THE PILLCAM SB CAPSULE INCLUDING THE AGILE PATENCY SYSTEM, CT ENTEROGRAPHY, OR MR ENTEROGRAPHY. THE ARTICLE WAS PUBLISHED AS: DE PALMA G. ET AL. CAPSULE IMPACTION PRESENTING AS ACUTE SMALL BOWEL PERFORATION: A CASES SERIES. JOURNAL OF MEDICAL CASE REPORTS 2012, 6:121.

    Description of Event or Problem · 1

    A PUBLICATION REGARDING TWO CASES OF PATIENTS WITH UNDIAGNOSED SMALL BOWEL STENOSIS PRESENTING ACUTE PERFORATION AFTER CAPSULE ENDOSCOPY. STRICTURES IN THE SMALL BOWEL WERE LIKELY THE INCITING MECHANISM LEADING TO ACUTE SMALL BOWEL OBSTRUCTION AND SUBSEQUENT DISTENSION AND PERFORATION ABOVE THE AREA OF MAXIMAL SEROSAL TENSION. CASE 1 WAS A (B)(6) WOMAN WHO UNDERWENT CAPSULE ENDOSCOPY BECAUSE OF RECURRENT POSTPRANDIAL CRAMPING PAIN AND IRON DEFICIENCY ANEMIA, IN THE SETTING OF NEGATIVE IMAGING STUDIES INCLUDING AN ABDOMINAL ULTRASOUND, UPPER ENDOSCOPY, COLONOSCOPY AND SMALL BOWEL FOLLOW THROUGH RADIOGRAPH. SHE DEVELOPED A SYMPTOMATIC BOWEL OBSTRUCTION AFTER 36 HOURS AND HAD EMERGENT SURGERY. CASE 2 WAS A (B)(6) MAN DEVELOPED ABDOMINAL DISTENSION, AND UNDERWENT EMERGENT SURGERY. THE EMERGENT SURGERY REMOVED THE CAPSULE, WHICH WAS IMPACTED AT A PREVIOUSLY UNDIAGNOSED ILEAL CROHN'S STRICTURE, LEADING TO PERFORATION.

    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 Hospitalization