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

Model Number LTF-S190-10

Device Problems Poor Quality Image (1408); Failure to Clean Adequately (4048)

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

Event Date 03/05/2024

Event Type  malfunction  

Event Description

It was observed that during the device inspection, the endoeye videoscope exhibited a poor image quality and had a dirty objective lens.There were no reports of patient involvement.

Manufacturer Narrative

The device was returned and the evaluation found the findings previously stated in section b5.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the customer's allegation of poor image was not confirmed.Therefore, a definitive root cause could not be established.The device evaluation found, since air leakage from the subject device was confirmed, it was possible that electronic components such as image sensor or circuit board inside scope connector corroded/ was broken/had temporary contact failure, causing the event.According to ifu, it was also possible that video connector was improperly connected/disconnected while the connector was dirty/wet, leading to abnormal image.The customer's allegation of dirty objective lens was confirmed.However, a definitive root cause for the dirt could not be established.Based on the results of the investigation, it is likely that the device was not properly reprocessed from the user facility and dirt had remained on the objective lens of the device due to air leakage.A review of the device history record found no deviations that could have caused or contributed to the reported issue.This issue is addressed in the instructions for use (ifu): user can detect/prevent the suggested poor image event in accordance with ifu below.Detection method is described in ltf-s190-5/10 operation manual chapter 3 preparation and inspection; preventive measures are described in ltf-s190-5/10 operation manual important information ¿ please read before use and chapter 5 troubleshooting.User can detect/prevent the suggested dirty objective lens event in accordance with ifu below: detection method is described in ltf-s190-5/10 operation manual chapter 3 preparation and inspection; preventive measures are described in ltf-s190-10 reprocessing manual chapter 5 reprocessing the endoscope.Olympus will continue to monitor the field performance of this device.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 18992108
• MDR Text Key: 339336908
• Report Number: 9610595-2024-06513
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170310386
• UDI-Public: 04953170310386
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/27/2024

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: Health Professional
• Device Model Number: LTF-S190-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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