BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE

    MDR report key: 11228270 · Received January 25, 2021

    Report

    Report Number
    8010047-2021-01861
    Event Type
    Malfunction
    Date Received
    January 25, 2021
    Report Date
    February 9, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GCJ
    PMA / PMN Number
    K123365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OMSC REVIEWED THE MANUFACTURE HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, THE REPORTED PHENOMENON COULD OCCUR DUE TO THE ELECTRICAL SIGNAL LINE OF THE CCD UNIT DETACHED OR BEEN SHORT-CIRCUIT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO OMSC FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A SCOPE COMMUNICATION ERROR (B30) OCCURRED DURING PREPARATION FOR USE. THEN, OLYMPUS INSPECTED THE DEVICE AT THE SERVICE DEPARTMENT OF OLYMPUS (B)(4) CO., LTD. AND FOUND THE FOLLOWING: THE ANGLE OF THE BENDING SECTION WAS NON-STANDARD. THE UNIVERSAL CORD WAS BENT AND WRINKLED. THE RUBBER ADHESIVE OF THE BENDING SECTION WAS WORN AND THERE WAS A GAP. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121061 ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE FLEX 3D DEFLECTABLE VIDEOSCOPE GCJ OLYMPUS MEDICAL SYSTEMS CORP. LTF-190-10-3D

    Patients

    Seq Age Sex Outcome Treatment
    1