BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE

    MDR report key: 12524092 · Received September 23, 2021

    Report

    Report Number
    8010047-2021-12206
    Event Type
    Malfunction
    Date Received
    September 23, 2021
    Report Date
    November 6, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. SINCE THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC), IT COULD NOT BE INVESTIGATED. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. IT COULD NOT BE SPECIFIED THE CAUSE OF THE REPORTED PHENOMENON. HOWEVER BASED ON THE REPORT OF THE SERVICE DEPARTMENT OF OLYMPUS EUROPE SE & CO. KG (OEKG), OMSC CONSIDERED THERE WAS THE POSSIBILITY THIS PHENOMENON WAS ATTRIBUTED TO DETERIORATION OF GLUE WITH THE FOLLOWING CAUSES; A) STRESS ON THE DISTAL END OF THE SUBJECT DEVICE FROM OUTSIDE OF THE SUBJECT DEVICE B) CHEMICAL ATTACK FROM CHEMICAL AGENTS C) INFLUENCE OF STERILIZATION USING STERRAD 100S SHORT PROGRAM (A NON-OLYMPUS MULTI-PURPOSE STERILIZER) [NOTES] THIS EVENT IS THOUGHT TO BE PREVENTABLE FOR THE FOLLOWING THE INSTRUCTION MANUAL OF THE SUBJECT DEVICE DESCRIPTION: ¿OPERATION MANUAL: IMPORTANT INFORMATION - PLEASE READ BEFORE USE: PRECAUTIONS: DO NOT STRIKE, HIT, OR DROP THE ENDOSCOPE¿S DISTAL END, RIGID PORTION, BENDING SECTION, CONTROL SECTION, UNIVERSAL CORD, VIDEO CONNECTOR, OR LIGHT GUIDE CONNECTOR. ALSO, DO NOT BEND, PULL, OR TWIST THE ENDOSCOPE¿S DISTAL END, RIGID PORTION, BENDING SECTION, CONTROL SECTION, UNIVERSAL CORD, VIDEO CONNECTOR, OR LIGHT GUIDE CONNECTOR WITH EXCESSIVE FORCE. THE ENDOSCOPE MAY BE DAMAGED AND COULD CAUSE PATIENT INJURY, BURNS, BLEEDING, AND/OR PERFORATIONS. IT COULD ALSO CAUSE PARTS OF THE ENDOSCOPE TO FALL OFF INSIDE THE PATIENT. REPROCESSING MANUAL: 3.1 COMPATIBILITY SUMMARY: LIST OF COMPATIBLE METHODS VALIDATED IN TERMS OF MATERIAL DURABILITY: STERRAD(R) 100S/NX(R) /100NX(R): STERILIZATION BY STERRAD(R) 100S/NX(R) /100NX(R) SYSTEM MAY DETERIORATE THE ADHESIVE OF THE INSERTION SECTION. DEPENDING ON THE CIRCUMSTANCES, REPLACEMENT OF THE INSERTION SECTION MAY BE REQUIRED. BEFORE USE, CONFIRM THAT THE ENDOSCOPE IS FREE FROM ANY DAMAGE OR OTHER IRREGULARITIES. FOR FURTHER DETAILS, CONTACT OLYMPUS.¿ IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED TO THE SERVICE DEPARTMENT OF (B)(4) BUT HAS NOT BEEN RETURNED TO OMSC. THE SERVICE DEPARTMENT OF (B)(4) CHECKED THE SUBJECT DEVICE FOR EVALUATION AND CONFIRMED THE REPORTED PHENOMENON. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 0

    OLYMPUS WAS INFORMED BY THE USER FACILITY THAT THE ADHESIVES ON THE BENDING SECTION WERE WORN AGAIN. DURING THE INCOMING INSPECTION AT THE SERVICE DEPARTMENT OF OLYMPUS (B)(4), SERIOUS DETERIORATIONS CAUSING SIGNIFICANT CRACKING OF THE ADHESIVES ON THE BENDING SECTION OF THE SUBJECT DEVICE WERE CONFIRMED. ADDITIONALLY THE ADHESIVES AROUND THE OBJECTIVE LENSES WERE DETERIORATED WITH MISSING PARTS. THE OCCURRENCE DATE OF THE EVENT IS UNKNOWN. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1421022 ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE FLEX DEFLECTABLE VIDEOSCOPE GCJ OLYMPUS MEDICAL SYSTEMS CORP. LTF-S300-10-3D

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown