BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA HYSTEROVIDEOSCOPE

    MDR report key: 11033349 · Received December 17, 2020

    Report

    Report Number
    8010047-2020-10620
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Date of Event
    November 27, 2020
    Report Date
    January 18, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    HIH
    PMA / PMN Number
    K022445
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR THE EVALUATION. OMSC CHECKED AND CONFIRMED FOLLOWINGS; VISUAL INSPECTION RESULT; IT WAS NOT FOUND THE GREEN OR GRAY LIQUID FROM/AROUND THE SUBJECT DEVICE WHICH THE USER HAS FOUND. IT WAS FOUND THE HOLES ON THE BENDING RUBBER OF THE SUBJECT DEVICE. IT WAS FOUND THE SCRATCH ON THE ADHESIVE PART OF THE BENDING RUBBER SECTION OF THE SUBJECT DEVICE. AIR LEAK INSPECTION. IT WAS FOUND THE LEAK FROM THE BENDING RUBBER OF THE SUBJECT DEVICE. FUNCTION AND IMAGE INSPECTION. IT WAS FOUND NO ABNORMALITY FOR THE SUBJECT DEVICE. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER BASED ON THE USER REPORT AND THE EVALUATION, OMSC SURMISED THERE WAS THE POSSIBILITY THIS PHENOMENON WAS ATTRIBUTED TO THE HOLES ON THE BENDING RUBBER SECTION WHICH MADE THE LIQUID COME INTO THE SUBJECT DEVICE BECAUSE THE HOLES WERE FOUND AT THE OMSC INSPECTION. SINCE THERE WERE NO REPORTS THAT THE HOLES HAD FOUND AT REPROCESSING BEFORE/AFTER PROCEDURE, THE HOLES MIGHT HAVE OCCURRED AT THE HANDLING. ALSO SINCE IT WAS FOUND THE SCRATCH ON THE ADHESIVE PART OF THE BENDING RUBBER SECTION, THE BENDING RUBBER MIGHT HAD BEEN APPLIED SOME EXTERNAL FORCE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR EVALUATION. THE EXACT CAUSE HAS BEEN UNDER INVESTIGATION, THEREFORE 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

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT IT WAS FOUND GREEN/GRAY LIQUID CAME OUT FROM NEAR THE CONTROL BODY OF THE SUBJECT DEVICE JUST AFTER THE MANUAL CLEANING AFTER THE FIRST UNSPECIFIED DIAGNOSTIC PROCEDURE. THE USER CANCELED THE SECOND UNSPECIFIED DIAGNOSTIC PROCEDURE WHAT WAS SCHEDULED. THE USER ALSO REPORTED THAT THERE WAS NO ABNORMAL DURING THE MANUAL CLEANING OF THE SUBJECT DEVICE BEFORE THE PROCEDURE, AND DURING THE MANUAL CLEANING OF THE SUBJECT DEVICE AFTER THE PROCEDURE. ALSO THE GREEN AND GRAY LIQUIDS WERE COLORS WHICH THE USER NEVER HAD NOT SEEN. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1496791 VISERA HYSTEROVIDEOSCOPE HYSTEROVIDEOSCOPE HIH OLYMPUS MEDICAL SYSTEMS CORP. HYF-V

    Patients

    Seq Age Sex Outcome Treatment
    1