BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PILLCAM SB2 CAPSULE

    MDR report key: 2599538 · Received May 31, 2012

    Report

    Report Number
    9710107-2012-01440
    Event Type
    Injury
    Date Received
    May 31, 2012
    Report Date
    May 31, 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 INDICATE THAT PILLCAM SB CAPSULES ARE CONTRAINDICATED FOR USE IN PTS 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 PTS BEFORE ADMINISTRATION OF THE PILLCAM SB CAPSULE INCLUDING THE AGILE PATENCY SYSTEM, CT ENTEROGRAPHY, OR MR ENTEROGRAPHY. THE ARTICLE WAS PUBLISHED AS: YITZHAK A ET AL. SMALL BOWEL PERFORATION AFTER CAPSULE ENDOSCOPY IN A PT WITH OCCULT GASTROINTESTINAL BLEEDING AND UNDIAGNOSED CROHN'S DISEASE. AM SURG. 2012 MAR; 78(3): 159-61. THE PUBLICATION IS ATTACHED TO THIS REPORT.

    Description of Event or Problem · 1

    (B)(6). A (B)(6) WOMAN WAS ADMITTED WITH A SUDDEN ONSET OF SEVERE ABDOMINAL PAIN, VOMITING, AND CONSTIPATION. ABOUT 24 HOURS BEFORE HER PRESENTATION, SHE HAD UNDERGONE A WCE FOR OGIB. HER PAST MEDICAL HISTORY INCLUDED A RIGHT HEMI-COLECTOMY 5 YEARS BEFORE HER CURRENT ADMISSION FOR A SUSPECTED CECAL TUMOR, WHICH TURNED OUT TO BE A NONSPECIFIC CHRONIC INFLAMMATORY MASS BY PATHOLOGY. SHE HAD ALSO BEEN SUFFERING FROM IRON DEFICIENCY ANEMIA FOR THE PAST 6 YEARS BEFORE AND AFTER HER RIGHT HEMI-COLECTOMY. PHYSICAL EXAMINATION SHOWED A FEVER OF 38.6 DEGREES CELSIUS, MILD TACHYPNEA, AND A DISTENDED AND DIFFUSELY TENDER ABDOMEN. PLAIN ABDOMINAL FILM AND A CT SCAN OF THE ABDOMEN REVEALED A CAPSULE ENDOSCOPE IMPACTED IN THE DISTAL SMALL BOWEL LOCATED IN THE RIGHT ILIAC FOSSA. THE PT WAS TAKEN TO AN EMERGENT LAPAROTOMY AND A PERFORATED, FRIABLE, AND EDEMATOUS TERMINAL ILEUM WAS FOUND AND RESECTED; AN ILEOSTOMY WITH MUCUS FISTULA WAS PERFORMED. THE PATHOLOGY REPORT REVEALED FINDINGS CONSISTENT WITH AN ACTIVE CROHN'S DISEASE OF THE SMALL BOWEL. THE PT HAD 27 DAYS OF HOSPITALIZATION IN WHICH SHE REQUIRED A REOPERATION FOR ABDOMINAL LAVAGE, AN INTENSIVE CARE UNIT STAY FOR VASOPRESSOR SUPPORT, AND A SUCCESSFUL TREATMENT FOR SUBGLOTTIC STENOSIS.

    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 63 YR Hospitalization| R