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

Model Number LTF-S190-10

Device Problem Communication or Transmission Problem (2896)

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

Event Type  malfunction  

Event Description

The customer returned the endoeye flex deflectable videoscope because it displayed an error code e216 (scope communication error) when the up/down angulation control was used.It is unknown when the event occurred.No patient injury reported.

Manufacturer Narrative

The device was returned to olympus medical for evaluation.During testing, the reported error e216 was confirmed.In addition, there was no image on the monitor when scope was positioned at certain angles.At this time, the investigation has determined the issues may have occurred due to damage to the image sensor unit or mounting components on the electrical board.In addition, the following non-reportable malfunctions were found during the device evaluation: insufficient angle, bending section scratches, bending section adhesion chip, image guide snake tube backlash, video connector deformation, video connector damaged.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

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 root cause of the suggested events could not be concluded, although it can be presumed that the events occurred due to the damage of image sensor unit (disconnection, etc.) or breakage of the mounting components (ic chip, capacitor, etc.) of the electric board due to use stress, external factors, or handling.The events can be detected/prevented by following the inspection method for the event is described as follows in ¿chapter 3 preparation and inspection, section 3.8 inspection of the endoscopic system¿ as below."[inspection of the endoscopic image].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." 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: 16808748
• MDR Text Key: 314113609
• Report Number: 9610595-2023-06660
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170310386
• UDI-Public: 04953170310386
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/19/2023

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-S190-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/26/2023
• Initial Date FDA Received: 04/25/2023
• Supplement Dates Manufacturer Received: 04/24/2023
• Supplement Dates FDA Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2014
• 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