BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAJ-2028-J EC-S10 SET

    MDR report key: 6676140 · Received June 28, 2017

    Report

    Report Number
    8010047-2017-00793
    Event Type
    Malfunction
    Date Received
    June 28, 2017
    Date of Event
    June 2, 2017
    Report Date
    March 12, 2018
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    NEZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A SUPPLEMENTAL REPORT FOR MFR REPORT #8010047-2017-00793 TO PROVIDE DEVICE EVALUATION RESULTS. OMSC CONTINUED TO INVESTIGATE THE REFERENCED DEVICES, HOWEVER THE PHENOMENON COULD NOT BE DUPLICATED. THE EXACT CAUSE OF THIS PHENOMENON CANNOT BE CONCLUSIVELY DETERMINED, HOWEVER THERE IS THE POSSIBILITY OF THIS PHENOMENON IS ATTRIBUTED TO THE FOLLOWING. SINCE THE MAJ-2028 REMAINED IN THE PATIENT¿S ESOPHAGUS, THE DISTANCE BETWEEN THE ANTENNA UNIT AND THE MAJ-2028 MIGHT INCREASE. ALSO, THERE MIGHT BE THE EFFECT OF THE DIRECTIVITY OF THE ANTENNA UNIT. CONSEQUENTLY THE ANTENNA UNIT COULD NOT RECEIVE THE IMAGES FROM THE MAJ-2028 TEMPORARILY. OMSC STATED THE COUNTER MEASURES AGAINST ABNORMALITIES OF THE DEVICES IN THE INSTRUCTION MANUAL OF THE DEVICES. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE REFERENCED MAJ-2028 WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP.(OMSC) FOR EVALUATION. THE REFERENCED MAJ-2028 WAS ACTIVATED BY THE ACTIVATOR WITHOUT ANY PROBLEM. ALSO THE RECORDER RECEIVED AND DISPLAYED THE ENDOSCOPIC IMAGE OF THE MAJ-2028 WITHOUT ANY PROBLEM. HOWEVER, WHEN THE MAJ-2028 WAS MOVED APPROXIMATELY 12CM AWAY FROM THE RECORDER, THE RECORDER COULD NOT RECEIVE AND DISPLAY THE ENDOSCOPIC IMAGE. OMSC CHECKED THE MANUFACTURE HISTORY OF THE REFERENCED MAJ-2028, THERE WAS NO IRREGULARITY FOUND. FURTHERMORE, THE EVALUATION IS IN PROGRESS AT THIS TIME. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    BEFORE THE CAPSULE ENDOSCOPY, THE FACILITY HAD CONFIRMED THAT THE RECORDER HAD RECEIVED THE CAPSULE ENDOSCOPIC IMAGE OF THE MAJ-2028 CORRECTLY, AND THEN THE PATIENT INGESTED THE MAJ-2028 TO START THE SMALL INTESTINAL CAPSULE ENDOSCOPY. HOWEVER IMMEDIATELY AFTER THE STARTING FROM CAPSULE ENDOSCOPY, NOISE APPEARED IN THE ENDOSCOPIC IMAGE ON THE DISPLAY PANEL OF THE RECORDER THEN THE ENDOSCOPIC IMAGE DISAPPEARED. EVEN THOUGH THE FACILITY CYCLED THE POWER OF THE RECORDER AND RE-ATTACHED THE RECORDER TO THE PATIENT, THE ENDOSCOPIC IMAGE WAS NOT DISPLAYED ON THE DISPLAY PANEL OF THE RECORDER. DURING THE CAPSULE ENDOSCOPY, THE PATIENT DID NOT HAVE ANY ELECTRONIC DEVICE. SINCE THE MAJ-2028 REMAINED IN THE PATIENT¿S ESOPHAGUS, THE PHYSICIAN RETRIEVED THE MAJ-2028 ENDOSCOPICALLY AND THE CAPSULE ENDOSCOPY WAS CANCELED. THE THREE DAYS AFTER, THE PATIENT UNDERWENT AGAIN THE CAPSULE ENDOSCOPY BY ANOTHER MAJ-2028 AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEM. THERE WAS NO REPORT OF THE PATIENT¿S INJURY REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456334 MAJ-2028-J EC-S10 SET NEZ OLYMPUS MEDICAL SYSTEMS CORP. MAJ-2028

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR