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

Model Number LTF-S190-5

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 annual maintenance.During the inspection, the reported issue could not be confirmed.It is likely that the defect was caused due to breakage of image sensor unit including disconnection by stress of repeated use, external factors, or handling.The instruction manual operation manual state: ¿chapter 3 preparation and inspection, 3.8 inspection of the endoscopic system¿ describes the following warning. 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.A manufacturing and quality control review was performed for the affected serial number without showing any non-conformities or deviations regarding the described issues.Olympus will continue to monitor the field performance of this device.

Event Description

It was reported to olympus that the image comes and goes on a videoscope.It is unknown when the reported issue occurred.There was no patient injury or adverse event reported to olympus.

• 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: 17465809
• MDR Text Key: 321226712
• Report Number: 9610595-2023-11206
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K201832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/04/2023

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: Other
• Device Model Number: LTF-S190-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/06/2023
• Initial Date FDA Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2015
• 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