BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIROCAM CAPSULE ENDOSOPE SYSTEM

    MDR report key: 9589434 · Received January 14, 2020

    Report

    Report Number
    3007244127-2019-12001
    Event Type
    Injury
    Date Received
    January 14, 2020
    Date of Event
    July 2, 2019
    Report Date
    December 11, 2019
    Manufacturer
    INTROMEDIC CO.,LTD.
    Product Code
    NEZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVES REGARDING THE EVENT ARE AS FOLLOWS; AFTER COMPLETING THE PROCEDURE, IT NEEDS TO BE CONFIRMED THAT THE CAPSULE HAS BEEN EXCRETED AND IT IS STATED ON THE PAGE 1-17 OF THE USER MANUAL. HOWEVER, ACCORDING TO THE CUSTOMER, THEY DIDN'T CONFIRM THE EXCRETION OF THE CAPSULE OUT FROM THE PATIENT'S BODY. IN ADDITION, THEY REPORTED US THAT THIS WAS BECAUSE OF A MISHANDLING BY THE STAFF AND THE CAPSULE WAS REMOVED BY SURGERY. ALSO, THERE WAS NO PATIENT INJURY RESULTING FROM THE RETAINED DEVICE. FOR THE ABOVE MENTIONED REASONS, IT IS CONCLUDED THAT THIS IS NOT DUE TO THE PRODUCT PROBLEM.

    Description of Event or Problem · 1

    A PATIENT WAS INVESTIGATED WITH MIROCAM ON (B)(6) 2016 IN (B)(6) HOSPITAL. THE CAPSULE WAS NEVER PASSED TO THE COLON, BUT THIS WAS NOT FOLLOWED UP DUE TO A MISHANDLING BY THE STAFF. THREE YEARS LATER THE CAPSULE WAS SEEN IN THE SMALL INTESTINE ON X-RAY AND HAD TO BE REMOVED BY SURGERY. PART OF THE SMALL INTESTINE WHERE THE CAPSULE WAS SITUATED ALSO HAD TO BE REMOVED. SINCE ENDOSCOPIC ATTEMPTS TO EXTRACT IT WAS NOT SUCCESSFUL, THE PATIENT HAD TO GO THROUGH SURGERY AND REMOVE A PIECE OF THE SMALL INTESTINE WHERE THE CAPSULE WAS STUCK. THE CAPSULE WAS REMOVED BY SURGERY ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49160 MIROCAM CAPSULE ENDOSOPE SYSTEM INGESTIBLE TELEMETRIC GASTROINTESTINAL CAPSULE IMAGING SYSTEM NEZ INTROMEDIC CO.,LTD. MC1200-G

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization