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

Model Number LTF-S190-5

Device Problems Image Display Error/Artifact (1304); Communication or Transmission Problem (2896)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned and evaluated, and the customer¿s allegation of generation of noise and error e226 and e227 was not confirmed.Device evaluation found that due to damage on charged coupled device unit, b30(scope communication) had occurred, there was no scope id data, bending section cover had a scratch, adhesive on bending section cover had a chip, due to a dent on bending tube, bending angle in up direction exceeded the standard value, video connector case had a crack, universal cord had a scratch, video connector had a crack, video connector was deformed, due to a dent on bending tube, and bending angle in up direction exceeded the standard value.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.

Event Description

The olympus representative reported (on behalf of the customer) that the endoeye flex deflectable videoscope had generation of noise and encountered error e226 and e227 (communication error).There were no reports of patient harm.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Information added to the fields: h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 7 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the three events were related due to the damage of image sensor unit (disconnection, etc.) or breakage of the mounting components (integrated circuit chip, capacitor, etc.) of the electric board due to use stress, external factors, or handling.However, the root cause cannot be identified.The event can be detected/prevented by following the instructions for use which state: the instruction manual operation manual¿ chapter 3 preparation and inspection, 3.8 inspection of the endoscopic system¿ describes the following warning.Inspection of the endoscopic image: confirm that the white light imaging 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 white light imaging and narrow band imaging 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 white light imaging and narrow band imaging 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 white light imaging and narrow band imaging endoscopic images do not momentarily disappear or display any other irregularities.Olympus will continue to monitor field performance for 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17819455
• MDR Text Key: 324287241
• Report Number: 9610595-2023-14084
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170434648
• UDI-Public: 04953170434648
• 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: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2023

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-S190-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/30/2023
• Initial Date FDA Received: 09/26/2023
• Supplement Dates Manufacturer Received: 11/08/2023
• Supplement Dates FDA Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2016
• 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