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

Model Number LTF-S190-10

Device Problem Image Display Error/Artifact (1304)

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

Event Type  malfunction  

Event Description

The customer reported to olympus, the endoeye flex deflectable videoscope displayed a noisy image.Vertical bands appeared while moving the universal cord.The device was returned and an evaluation revealed, the image had an abnormal color tone (magenta color only).This report is being submitted to capture the reportable malfunction found during evaluation.There were no reports of patient harm associated with the event.

Manufacturer Narrative

An evaluation of the returned device confirmed the customer allegation.Due to damage on charge coupled device (ccd) unit, a noise image occurs.Bending section cover had a scratch.Adhesive on bending section cover was chipped.Due to wear of angle wire, bending angle in up direction does not meet the standard value.Universal cord is dirty.Protector of universal cord on scope connector side had a scratch.The investigation is ongoing and follow-up with the user facility is currently being performed.A supplemental will be submitted in completion of investigation or if any additional information is available.

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 event was unable to be identified; however, the event most likely occurred due to a malfunction of the image sensor unit, a board inside the video connector, or a problem on the system side.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: 16045812
• MDR Text Key: 307998407
• Report Number: 9610595-2022-06054
• Device Sequence Number: 1
• Product Code: GCJ
• 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,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2023

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: 12/01/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/24/2022
• Supplement Dates Manufacturer Received: 01/31/2023
• Supplement Dates FDA Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2015
• 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