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

Model Number LTF-S190-10

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that the endoeye flex deflectable videoscope had a communication error.Upon inspection and evaluation, communication error, image noise and image blackout reported.There was no report of patient harm or user injury associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunctions found during incoming inspection and evaluation.

Manufacturer Narrative

The device was returned to olympus for inspection, and the customer's reported issue communication error was not confirmed, however image noise and image blackout reported were confirmed.The following findings were also noted during device evaluation: due to damage on charged coupled device (ccd) unit, the image is not displayed, due to damage on circuit board of video plug section, image noise occurs, and an image cannot be displayed, due to a crack on distal end, water tightness is lost, scratches and a chip noted on the device, due to damage on control section, angulation lever does not move smoothly, due to damage on lock engagement lever(sp), bending section cannot be fixed firmly, and due to damage on the control section, the angulation lever does not move smoothly.Based on the results of the investigation, it is likely that the following led to the malfunction: a definitive root cause cannot be identified.Since it is judged as a failure of the scope from the inspection result report (b)(4), which is ¿no image¿ is confirmed, so it is judged that other devices involved evaluation is unnecessary.A device history review revealed no issues that could have caused or contributed to the reported issue.The subject device had no nonconformity at manufacturing.This issue is addressed in the instructions for use (ifu): the inspection method for the suggested event1/2/3 is described as follows in the operation manual "chapter 3 preparation and inspection 3.8 inspection of the endoscopic system in the operation manual.¿ confirm that the whitte light imaging (wli) and narrow band imaging endoscopic images are normal.1 before inspection, wipe the objective lens using clean lint-free cloths moistened with saline solution or sterilized water.2 observe the palm of your hand in the wli and nbi endoscopic images.3 confirm that light is output from the endoscope¿s distal end.4 adjust the brightness level as appropriate.5 confirm that the wli and nbi endoscopic images are free from noise, blur, fog, or other irregularities.6 turn the angulation control levers slowly in each direction until it stops.7 confirm that the wli and nbi endoscopic images do not momentarily disappear or display any other irregularities.Olympus will continue to monitor the field performance of this device.

• Brand Name: ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE
• Type of Device: FLEX 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18081821
• MDR Text Key: 327622348
• Report Number: 9610595-2023-16595
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170310386
• UDI-Public: 04953170310386
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LTF-S190-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1