BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PILLCAM SB2 CAPSULE

    MDR report key: 2572295 · Received May 8, 2012

    Report

    Report Number
    9710107-2012-01375
    Event Type
    Injury
    Date Received
    May 8, 2012
    Report Date
    May 6, 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OF A (B)(6) PT WITH A RETAINED PILLCAM SB2 CAPSULE. THE CUSTOMER REPORTED THAT 72 HRS AFTER THE PT UNDERWENT CAPSULE ENDOSCOPY SHE WAS ADMITTED TO THE EMERGENCY DEPARTMENT WITH A TWO DAYS HISTORY OF PROGRESSIVELY WORSENING ABDOMINAL DISTENTION AND PERI-UMBILICAL PAIN, AND COMPLAINTS OF NAUSEA AND VOMITING. ACCORDING TO THE CUSTOMER ABDOMINAL EXAM REVEALED A SOFT BUT GROSSLY DISTENDED ABDOMEN WITH REBOUND TENDERNESS OVER THE PERI-UMBILICAL REGION, AS WELL AS PERCUSSION TENDERNESS. X-RAY ABDOMINAL SHOWED AIR FLUID LEVELS WITH A DISTENDED SMALL BOWEL AND A RETAINED CAPSULE ENDOSCOPE IN THE TERMINAL ILEUM CONSISTENT WITH A SMALL BOWEL OBSTRUCTION. INTRA-OPERATIVELY, A 3 CM SEGMENT OF STRICTURED BOWEL WAS NOTED WITH THE CAPSULE ENDOSCOPE OCCLUDING THE BOWEL AT THE PROXIMAL END OF THE STRICTURE. THE STRICTURED SEGMENT ALONG WITH CAPSULE ENDOSCOPE WAS RESECTED AND NORMAL APPEARING DISTAL AND PROXIMAL BOWEL WERE ANASTOMOSED. HISTOPATHOLOGY OF THE RESECTED SPECIMEN SHOWED INFLAMMATORY INFILTRATION OF THE WALL WITH FIBROSIS OF THE MUSCULARIS PROPRIA, SUGGESTIVE OF NON-SPECIFIC CHRONIC INFLAMMATION. ANALYZED IMAGES FROM THE OPERATIVELY RETRIEVED CAPSULED SHOWED MULTIPLE ANGIODYSPLASTIC LESIONS IN THE PROXIMAL SMALL BOWEL.

    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 65 YR Hospitalization| R