BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PILLCAM SB 3 CAPSULE, 1-PACK

    MDR report key: 6124040 · Received November 23, 2016

    Report

    Report Number
    9710107-2016-01100
    Event Type
    Injury
    Date Received
    November 23, 2016
    Date of Event
    May 16, 2016
    Report Date
    November 3, 2016
    Manufacturer
    GIVEN LTD (ISRAEL)
    Product Code
    NEZ
    PMA / PMN Number
    K123864
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, A PROCEDURE WAS PERFORMED USING AN SB3 CAPSULE. A PATENCY CAPSULE WAS NOT USED. THE STUDY SHOWED A DISTAL SMALL BOWEL ULCERATION AND IT APPEARED THAT CECUM HAD BEEN REACHED. IN (B)(6) 2016, THE PATIENT WAS ADMITTED TO ANOTHER HOSPITAL WITH SEPSIS AND REQUIRED VENTILATION. AT THIS TIME, THE RETAINED CAPSULE WAS IDENTIFIED USING IMAGING. THE PHYSICIAN SPOKE TO THE FAMILY AGAIN IN (B)(6), AND THE PATIENT HAD RECOVERED FROM THE SEPSIS. THE FAMILY HAD CONSULTED WITH TWO INSTITUTIONS REGARDING HOW TO MANAGE THE RETAINED CAPSULE, AND A SURGEON AT ANOTHER HOSPITAL ATTEMPTED TO REMOVE IT SURGICALLY. REPORTEDLY, THERE WERE SIGNIFICANT ADHESIONS FROM THE PRIOR SURGERIES AND THE SMALL BOWEL WAS FRIABLE, RESULTING IN MULTIPLE PERFORATIONS, SO A PARTIAL SMALL BOWEL RESECTION WAS PERFORMED AND THE PROCEDURE WAS ABANDONED WITHOUT RETRIEVAL OF THE CAPSULE. THE PATIENT IS CURRENTLY AT HOME, HAS RECOVERED FROM THE SURGERY AND SEPSIS, AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777042 PILLCAM SB 3 CAPSULE, 1-PACK SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE NEZ GIVEN LTD (ISRAEL) FGS-0501 30640X

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other| R