BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSULE DEPLOYMENT DEVICE

    MDR report key: 20771107 · Received November 25, 2024

    Report

    Report Number
    20771107
    Event Type
    Malfunction
    Date Received
    November 25, 2024
    Date of Event
    October 18, 2024
    Report Date
    November 15, 2024
    Manufacturer
    STERIS CORPORATION / UNITED STATES ENDOSCOPY GROUP
    Product Code
    NEZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS RN (REGISTERED NURSE) WAS ASSISTING DR. WITH A VCE (VIDEO CAPSULE ENDOSCOPY). OUR FIRST JOB IS TO ENSURE THE CAP THAT HOLDS THE CAPSULE IS SCREWED ONTO THE DELIVERY DEVICE. HOWEVER, WE DID HAVE SOME ISSUES DOING THIS. I ATTEMPTED FIRST, THEN DR. WAS ABLE TO GET IT ON. AS WE WERE ADVANCING THE SCOPE INTO THE ESOPHAGUS, WE NOTICED THAT THE WHOLE CAPSULE HAD CAME OFF OF THE DELIVERY DEVICE BEFORE ENTERING THE ESOPHAGUS. THUS, DR. QUICKLY USED THE SCOPE TO GUIDE THE PILL DOWN INTO THE STOMACH. SADLY, WE THEN NOTICED THAT THE CAP WAS STILL ON THE CAPSULE, AND WE NEED THAT PART OFF WHILE ITS TRAVELING THROUGH THE PATIENT¿S GI TRACT. THUS, WE WENT BACK IN WITH THE EGD (ESOPHAGOGASTRODUODENOSCOPY) SCOPE AND A ROTH NET TO RETRIEVE THE PILL. THE PROVIDERS ABORTED PROCEDURE AFTER THAT AND DECIDED TO HAVE PATIENT (PT) TRY AND SWALLOW IT AT BEDSIDE ONCE IN RR (RECOVERY ROOM). ONCE PT WAS AWAKE ENOUGH AND ABLE TO FOLLOW INSTRUCTIONS. THIS RN HAD PT SWALLOW VCE WITH SIPS OF WATER. PATIENT WAS SUCCESSFULLY ABLE TO SWALLOW THE PILL WITH NO COMPLICATIONS. THEREFORE, WE WERE STILL ABLE TO GET THE PROCEDURE DONE BUT PROVIDERS DID NOT FEEL COMFORTABLE PULLING ANOTHER DEPLOYMENT DEVICE BECAUSE OF THE PREVIOUS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2014953 CAPSULE DEPLOYMENT DEVICE SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE NEZ STERIS CORPORATION / UNITED STATES ENDOSCOPY GROUP

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female