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

Model Number LTF-S190-10

Device Problem Image Display Error/Artifact (1304)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found that due to damage on the video plug and a cut on charged coupled device cable, the color tone of the image was abnormal.In addition to the reportable malfunction, the following were noted: due to a scratch on the electrical contact of the video connector and damage on the charged coupled device unit, a noisy image occurred; due to wear of the angle wire, the bending angle in the up direction did not meet the standard value; the adhesive on the bending section cover had a chip; switch 1 had discoloration.Additionally, the following components had a scratch: the upward/downward angulation plate, the video connector case, the video connector, the angulation lever, the control unit, the grip, the light guide connector, the light guide-cover glass, the right/left lever, the right/left plate, switch 1, and switch 2.A review of the device history record found the device had a non-conformity during manufacture, however the device was shipped in accordance with specifications, and therefore, had no deviations that could have caused or contributed to the reported issue.It has been over 10 years since the subject device was manufactured.Based on the results of the investigation, it is likely that one of the following led to the malfunction: breakage to the image sensor unit, such as disconnection caused by stress of repeated use, external factors, handling, or a defect on the components mounted on the electric circuit board, including the integrated circuit chip and capacitor.However, a definitive root cause cannot be identified.This issue is addressed in the instructions for use (ifu): ¿chapter 3 preparation and inspection, 3.8 inspection of the endoscopic system" confirm that the wli and nbi 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.(see figure 3.23) 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.

Event Description

The customer reported to olympus that the endoeye flex deflectable videoscope had image noise.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was found: damage on the video plug causing an abnormal color tone of the image.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

• 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: 17990460
• MDR Text Key: 326389536
• Report Number: 9610595-2023-15691
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/23/2023

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
• Device Operator: Health Professional
• Device Model Number: LTF-S190-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/27/2023
• Initial Date FDA Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2013
• 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