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

Model Number LTF-S190-10

Device Problem Poor Quality Image (1408)

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

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record found no deviations that could have caused or contributed to the reported issue.Although the cloudy image was likely due to damage to the stress of repeated use, external factors or handling, however a definitive root cause of the cloudy image could not be identified.The customer may be able to reduce and prevent occurrence of the event by handling device in accordance with the following ifu : the inspection method for the suggested event is described in the operation manual ¿chapter 3 preparation and inspection 3.8 inspection of the endoscopic system".If additional information becomes available at a later date, this report will be supplemented.Olympus will continue to monitor the field performance of this device.

Event Description

It was observed during the device inspection, that the deflectable videoscope exhibited cloudiness in the image due to damage to the objective lens.There were no reports of patient involvement.

• 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: 19116790
• MDR Text Key: 341016712
• Report Number: 9610595-2024-07969
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170434662
• UDI-Public: 04953170434662
• 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: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/16/2024

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-S190-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/22/2022
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2013
• 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