MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE

Model Number	LTF-190-10-3D
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The olympus employee reported that the endoeye flex 3d deflectable videoscope was found to have pinhole on the bending section rubber.Inspection and testing of the returned device found foggy image was produced on the endoscope.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found pinhole on bending section rubber due to which water tightness is lost.Due to damage on charged couped device unit, foggy image occurs.Bending section rubber adhesive has a chip.Label on light guide connector is peeled.Light guide-cover glass has a scratch.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation (h6/h10).A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause could not be determined.It is likely the reported issue occurred due to breakage or disconnection of the image sensor unit.The cause of the breakage/disconnection was one of the following: stress from repeated use, external factors, handling, and/or a failure in the parts mounted on the electrical circuit board such as the integrated circuit chip and capacitor.The event can be detected by following the instructions for use (ifu) which state: "[inspection of the endoscopic image] 1.Before inspection, wipe the objective lens using clean lint-free cloths moistened with saline solution or sterilized water.2 wear the 3d glasses supplied with the 3d monitor.3 observe the palm of your hand in the wli and nbi endoscopic images.4 confirm that light is output from the endoscope¿s distal end.5 adjust the brightness level as appropriate.6 take off the 3d glasses and confirm that the right-eye and left-eye images are displayed the same." olympus will continue to monitor field performance for this device.

• Brand Name: ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE
• Common Device Name: FLEX 3D DEFLECTABLE VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17148452
• Report Number: 9610595-2023-08968
• Device Sequence Number: 20288112
• Product Code: GCJ
• UDI-Device Identifier: 04953170340741
• UDI-Public: 04953170340741
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LTF-190-10-3D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown