BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAJ-2028-J EC-S10 SET

    MDR report key: 6566201 · Received May 15, 2017

    Report

    Report Number
    8010047-2017-00586
    Event Type
    Malfunction
    Date Received
    May 15, 2017
    Date of Event
    April 17, 2017
    Report Date
    November 6, 2017
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    NEZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OMSC PERFORMED THE ADDITIONAL SURVEY TO THE USER, AND RECEIVED THE FOLLOWING INFORMATION. THE USER CONFIRMED THAT THE LED OF THE CAPSULE ENDOSCOPE LIGHTED WHEN THE CAPSULE ENDOSCOPE WAS ACTIVATED. THE USER DID NOT PERFORM RECEIVING CHECK OF ENDOSCOPIC IMAGE BEFORE ADMINISTERING THE CAPSULE ENDOSCOPE TO THE PATIENT. THE USER THOUGHT THAT THE CAPSULE ENDOSCOPE WAS ACTIVATED, BUT THERE WAS A POSSIBILITY THAT HE FORGOT TO ACTIVATE IT. OMSC CONFIRMED THE INSPECTION DATA STORED IN THE CAPSULE WORKSTATION, AND CONFIRMED THAT THE ENDOSCOPIC IMAGE OF THIS INSPECTION WAS NOT RECORDED. AS A RESULT OF THESE INVESTIGATIONS, OMSC SURMISED THAT THIS EVENT OCCURRED BECAUSE THE USER FORGOT TO ACTIVATE THE ENDOSCOPE AND ADMINISTERED IT TO THE PATIENT. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE ENDOCAPSULE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OMSC INVESTIGATED THE ENDOCAPSULE AND FOUND THE FOLLOWING. OMSC CHECKED THE EXTERIOR OF THE ENDOCAPSULE. ANY ABNORMALITY WAS NOT FOUND. OMSC TRIED TO BOOT THE ENDOCAPSULE. THE ENDOCAPSULE BOOTED WITHOUT ANY ABNORMALITY. WITH THE ENDOCAPSULE RUNNING, OMSC DROPPED THE ENDOCAPSULE FROM A HEIGHT OF ABOUT 1M. ANY ABNORMALITY WAS NOT FOUND. OMSC FOUND THAT THE ENDOCAPSULE TRANSFERRED THE ENDOCAPSULE IMAGE TO THE RECEIVER UNIT WITHOUT ANY ABNORMALITY. OMSC CHECKED THE DEVICE HISTORY RECORD OF THE SUBJECT ENDOCAPSULE, AND THERE WAS NO IRREGULARITY FOUND. OMSC WILL CONTINUE THE INVESTIGATION ABOUT THIS EVENT. THE MAJ-2028 INSTRUCTION MANUAL STATES THE CORRESPONDING METHOD WHEN THERE IS AN ABNORMALITY. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    THE USER CONFIRMED THAT THE LIGHT OF THE ENDOCAPSULE WAS TURNED ON AND LET THE PATIENT TAKE THE ENDOCAPSULE. FOR A WHILE AFTER THAT, THE ENDOCAPSULE TRANSFERRED THE ENDOCAPSULE-IMAGE TO THE RECEIVER UNIT. FROM THE MIDDLE OF THE PROCEDURE, THE ENDOCAPSULE-IMAGE WAS NOT TRANSFERRED. THE USER REMOVED THE ENDOCAPSULE FROM THE PATIENT¿S STOMACH USING THE ENDOSCOPE BECAUSE THE ENDOCAPSULE WAS IN THE PATIENT¿S STOMACH AT THAT TIME. THE USER RE-PERFORMED THE CAPSULE ENDOSCOPY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349238 MAJ-2028-J EC-S10 SET NEZ OLYMPUS MEDICAL SYSTEMS CORP. MAJ-2028

    Patients

    Seq Age Sex Outcome Treatment
    1