BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 11780978 · Received May 5, 2021

    Report

    Report Number
    8010047-2021-05891
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Date of Event
    April 8, 2021
    Report Date
    May 6, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) BUT WAS RETURNED TO OLYMPUS REPAIR CENTER IN (B)(6) FOR EVALUATION. OLYMPUS REPAIR CENTER INSPECTED THE DEVICE AND CONFIRMED THE FOLLOWING: THE SCREW FOUND IN THE CONTROL SECTION WAS IDENTIFIED AS THE AD BOARD SCREW WE115255 PUK 2 X 2.5SA. THE SCREW HAS NOT BEEN REMOVED SINCE THE DEVICE WAS MANUFACTURED BECAUSE THE BLUE SCREW LOCKING ADHESIVE WAS APPLIED TO THE SCREW HOLE OF THE SCREW THAT CAME OFF. THE REPORTED EVENT MAY HAVE BEEN CAUSED BY LOOSENING DUE TO REPEATED USE. OMSC CONFIRMED THAT A MINUTE RED SCREW LOCKING ADHESIVE WAS ATTACHED TO THE TIP OF THE SCREW THAT CAME OFF FROM THE PHOTOS SENT BY OLYMPUS REPAIR CENTER. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, BECAUSE THE DEVICE HAS NOT BEEN RETURNED TO OMSC. HOWEVER, THERE IS POSSIBILITY THAT THE REPORTED EVENT WAS CAUSED BY THE FOLLOWING: BASED ON THE INFORMATION BELOW, IT IS POSSIBLE THAT THE DEVICE WAS SHOCKED OR VIBRATED DUE TO REPEATED USE, CAUSING THE AD BOARD SCREW TO LOOSEN AND REACH THE CONTROL SECTION FROM THE ENDOSCOPE CONNECTOR VIA THE UNIVERSAL CORD. ACCORDING TO THE INSPECTION RESULT BY THE OLYMPUS REPAIR CENTER, THE OLYMPUS REPAIR CENTER CONCLUDED THAT THE SCREW ON THE AD BOARD WAS LOOSENED DUE TO REPEATED USE. THE INSTRUCTION MANUAL PROVIDES THAT THE ENDOSCOPE MAY BE DAMAGED IF A LARGE FORCE IS APPLIED TO THE ENDOSCOPE CONNECTOR. THE SAME EVENT AS THE REPORTED EVENT HAS NOT OCCURRED IN THE SAME PRODUCT AS THE DEVICE IN THE PAST. BASED ON THE INFORMATION BELOW, IT IS POSSIBLE THAT THE SCREW ON THE AD BOARD WAS ACCIDENTALLY REMOVED AND NOT REATTACHED DURING THE PREVIOUS REPAIR, AND EXTRA SCREW WAS MIXED IN THE CONTROL SECTION. IT MAY BE THE SCREW THAT WAS REMOVED DURING THE LAST REPAIR, BECAUSE A MINUTE RED SCREW LOCKING ADHESIVE WAS ATTACHED TO THE TIP OF THE EXTRA SCREW FOUND IN THE CONTROL SECTION. ACCORDING TO THE REPAIR HISTORY, THE DEVICE WAS RETURNED TO (B)(4) ON JANUARY 27, 2021, AND WAS PREVIOUSLY REPAIRED. IN THE PAST SIMILAR CASES, IT WAS CONCLUDED THAT THE CAUSE WAS THAT EXTRA SCREW WAS MIXED IN DURING PAST REPAIR BY (B)(4). ACCORDING TO CAPA, IT WAS DETERMINED THAT WHEN THE DEVICE IS IMPACTED OR VIBRATED, THE SCREWS THAT SECURE THE AD BOARD AND THE ENDOSCOPE CONNECTOR UNIT LOOSEN BEFORE THE SCREWS ON THE AD BOARD. THE INSTRUCTION MANUAL PROVIDES PREVENTIVE MEASURES AGAINST THE REPORTED FAILURE MODE. DEVICE HISTORY RECORD (DHR) REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA.

    Description of Event or Problem · 1

    OLYMPUS INSPECTED THE DEVICE AT OLYMPUS REPAIR CENTER IN (B)(6) AND FOUND THAT THE AD BOARD SCREW IN THE ENDOSCOPE CONNECTOR WAS MISSING WHEN THE DEVICE WAS OPENED FOR REPAIR. THE CONTROL SECTION WAS DISASSEMBLED AND THERE WAS AN EXTRA SCREW OF THE SAME TYPE AS THE AD BOARD SCREW UNDER THE RELAY BOARD IN THE CONTROL SECTION. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674744 EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-HQ290

    Patients

    Seq Age Sex Outcome Treatment
    1