BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 11989375 · Received June 14, 2021

    Report

    Report Number
    8010047-2021-07456
    Event Type
    Malfunction
    Date Received
    June 14, 2021
    Report Date
    May 3, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    UDI-DI
    04953170334115
    PMA / PMN Number
    K112680
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE INFORMATION THAT WAS INADVERTENTLY LEFT OUT OF THE INITIAL MEDWATCH AND THE SUPPLEMENTAL MEDWATCH. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ENHANCEMENTS MADE TO THE COMPANY¿S MDR AND COMPLAINT HANDLING PROCESSES. CAPAS HAVE BEEN OPENED TO MANAGE THE ACTIONS THAT ARE BEING TAKEN TO REMEDIATE THIS ISSUE AND ENSURE ANY REQUIRED MDR REPORTING IS COMPLETED. THIS REPORT IS BEING SUBMITTED FOR THE REPORTABLE MALFUNCTION OF BLURRY IMAGE REPORTED BY THE CUSTOMER. THE SUBJECT DEVICE WAS RETURNED TO AN OLYMPUS SERVICE CENTER FOR EVALUATION. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, THE CUSTOMER'S COMPLAINT WAS NOT CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE MET ALL SPECIFICATIONS AT THE TIME OF SHIPMENT. BASED ON THE RESULTS OF THE LEGAL MANUFACTURER'S INVESTIGATION, ALTHOUGH A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED, IT IS LIKELY THAT A BLURRY IMAGE WAS DISPLAYED DUE TO FOLLOWING: THE ENTIRE IMAGE WAS BLURRED DUE TO DAMAGE TO THE CCD UNIT. THE ENTIRE IMAGE WAS BLURRED DUE TO SLIDING ERROR OF MOVABLE L-RANGE THAT OCCURRED IN THE ZOOM SCOPE. BLURRING THE ENTIRE IMAGE OCCURRED WITHIN THE ALLOWABLE RANGE. THE ENTIRE IMAGE WAS BLURRED DUE TO DAMAGE OR DEFORMATION OF THE CONNECTOR. THE FOLLOWING INFORMATION IS STATED IN THE IFU (INSTRUCTIONS FOR USE) WHICH MAY HELP TO PREVENT THE ISSUE: OPERATION MANUAL, INSPECTION OF THE ENDOSCOPIC SYSTEM, OPERATION MANUAL. IMPORTANT INFORMATION ¿ PLEASE READ BEFORE USE WARNINGS AND CAUTIONS. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE DEVICE WAS EVALUATED AT OLYMPUS REPAIR CENTER. DEVICE HISTORY RECORD REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. OMSC SURMISED THAT THE CHEMICALS WHICH WERE USED FOR PROCEDURE OR REPROCESSING REMAINED IN THE CHANNEL BY THE INSUFFICIENT REPROCESSING BY THE USER HANDLING. THE INSTRUCTION MANUAL PROVIDES PREVENTIVE MEASURES AGAINST THE REPORTED FAILURE MODE. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE LEGAL MANUFACTURER¿S CONTACT INFORMATION AND FACILITY REGISTRATION NUMBER. THE FACILITY REGISTRATION NUMBER IS (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC), BUT RETURNED TO OLYMPUS REPAIR CENTER FOR EVALUATION. ACCORDING TO THE EVALUATION, THE FOLLOWING WAS FOUND. THE UP AND DOWN KNOB OF ANGULATION WAS OUT OF STANDARDS DUE TO THE WORN ANGLE WIRE. THERE WAS A GAP ON THE BENDING SECTION RUBBER BONDING. UNIVERSAL CORD WAS CONTAMINATED. THE DEVICE COVER WAS CONTAMINATED. GRIP UNIT WAS CONTAMINATED. THE ENDOSCOPIC IMAGE BECAME FOGGY DUE TO THE CCD UNIT FAILURE. THE LIGHT BECAME ABNORMAL DUE TO THE LIGHT GUIDE LENS SCRATCHES. THE BODY CONTROL HAD LEAKAGE AND CORROSION. 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

    DURING THE PREPARATION FOR USE, THE USER FOUND THAT THE ENDOSCOPIC IMAGE HAD A FAILURE. THE USER RETURNED THE DEVICE TO OLYMPUS REPAIR CENTER. OLYMPUS REPAIR CENTER FOUND THAT FOREIGN MATERIAL WAS EXITED OUT FROM THE SUCTION CHANNEL OF THE DEVICE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892272 GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-H170 04953170334115

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown