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

Model Number LTF-S190-10

Device Problems Poor Quality Image (1408); Communication or Transmission Problem (2896)

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

Event Date 04/14/2024

Event Type  malfunction  

Manufacturer Narrative

The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the screen turned green and displayed error e231 scope malfunction, while using the flex video scope.The issue was discovered during a therapeutic procedure was completed with a similar device.There was no patient harm associated with the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the events were confirmed, and the device did not meet the standard specifications and function.The probable cause is that electrical load or stress had been applied to the electrical board in the image sensor due to energization.This was mounted on the image sensor unit embedded in the distal end of the endoscope.It was likely that static electricity had been inadvertently applied, or overcurrent had flown due to connection/disconnection while the system was powered on.Then, the electrical connecting status temporarily became poor, which exercised a negative impact to the image signal output to make it unstable.As a result, the image sensor unit became faulty (irregular), leading to the image irregularity.Moreover, overcurrent may have been applied due to connection/disconnection while the system was powered on, overcurrent from other devices or electrical wiring, or adhesion of dust and moisture to the electrical contacts on the system and those in the video connector.The instruction manual identifies the following related verbiage which could have detected the phenomenon: instructions, operation manual, chapter 3 "preparation and inspection", section 3.8 "inspection of the endoscopic system".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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19140355
• MDR Text Key: 340817251
• Report Number: 9610595-2024-08218
• 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,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/18/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: OTV-S700