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

Model Number LTF-S190-5

Device Problem No Display/Image (1183)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.During testing an image problem was confirmed; the device relayed an error b31 (scope communication error).This error was caused by damage to the insertion section at the charge coupled unit and damage to the video plug section of the circuit board.In addition, the device's bending section cover adhesive was chipped.The insertion section was loose; this impacted the quality of connection between the insertion section and the control unit.The following components were found scratched: bending section's cover, control unit, hand grip, right/left direction plate, angulation lever, switch button 1, universal cord, light guide connector, light guide cover glass, video connector case and video connector.The investigation is ongoing.A supplemental report will be submitted upon completion of investigation.

Event Description

The company representative reported on behalf of the customer that the endoeye flex deflectable videoscope displayed no image and an error occurred.The reported issue was observed during a diagnostic thoracoscopy.The intended procedure was completed with another device.Reportedly, the subject device was not originally prepared, and the intended procedure was delayed.The anesthesia time for the patient was extended.There was no report of patient or user injury due to 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.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the image sensor unit, the board inside the video connector, or the system was faulty.However, a definitive root cause cannot be established.The event can be prevented by following the instructions for use: "chapter 3 preparation and inspection 3.8 checking the function in combination with related equipment [inspection of endoscopic images] 1.Wipe the endoscope tip lens with sterile gauze moistened with saline or sterile water before inspection.2.Observe the palm etc.With normal light observation image and nbi observation image.3.Confirm that the illumination light is coming out.4.Adjust the amount of light to make it suitable brightness.5.Confirm that there are no abnormalities such as noise, blur, or cloudiness in the normal light observation image and the nbi observation image." 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: 17035202
• MDR Text Key: 316808723
• Report Number: 9610595-2023-08237
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170310355
• UDI-Public: 04953170310355
• 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: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• 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: 05/08/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2020
• 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