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

Model Number LTF-S190-5

Device Problem Image Display Error/Artifact (1304)

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

Event Date 09/14/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that the endoeye flex deflectable videoscope had no image.The issue was observed during preparation for use, and there were no reports of patient or user harm associated with this event.

Manufacturer Narrative

The device was returned to olympus for a device evaluation and the customer's allegation was confirmed.The device evaluation found the following: due to damage on ccd (charged coupled device) unit some image noise occurs and the image cannot be seen, due to damage on the ccd unit in the endoscope connector the color tone of the image is not proper, the adhesive on the bending section cover rubber had a chip, the control unit had a scratch, the grip had a scratch, switch 1 had a scratch, the right/left/ and the up/down levers both had a scratch, the right/left plate had a scratch, the angulation lever had a scratch, the light guide connector had a scratch, the light guide cover glass had a scratch, the video connector case had a scratch, the protector of the universal cord on the control section side had a scratch, the video connector had a scratch and a crack, and the label on the video connector was peeled.We could not specify the root cause of the suggested event since the actual item was not sent to mbc, however, we presume that the defect was caused due to breakage of image sensor unit including disconnection by stress of repeated use, external factors, or handling, or that the components including ic chip and capacitor, mounted on the electric circuit board had a defect.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The instruction manual operation manual ¿chapter 3 preparation and inspection, 3.8 inspection of the endoscopic system¿ describes the following warning.< 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: 17920426
• MDR Text Key: 325495678
• Report Number: 9610595-2023-15040
• 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,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2023

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-S190-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/12/2023
• Initial Date FDA Received: 10/12/2023
• Supplement Dates Manufacturer Received: 10/12/2023
• Supplement Dates FDA Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2011
• 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