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 Date 11/11/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned.The customer allegation was not confirmed; however, the occurrence is likely.Additionally, scratches were found throughout the device.The video connector had a crack.The investigation is ongoing.A supplemental will be submitted on completion of investigation or if any additional information is received.

Event Description

The company representative on behalf of the customer reported, the endoeye flex defelctable videoscope displayed abnormal color tone.The image was magenta /green.The issue was found during a laparoscopic surgery.The intended procedure was completed with another endoeye (model:ltf-s190-10 ).There was a delay of about three minutes to prepare another endoeye and to set the white balance from connecting to the endoscope system.There was no impact to the patient as a result of delay and there were no reports of 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 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: 15971278
• MDR Text Key: 308501729
• Report Number: 9610595-2022-05344
• 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,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/20/2023

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: 11/16/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 12/13/2022
• Supplement Dates Manufacturer Received: 12/23/2022
• Supplement Dates FDA Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2019
• 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: IMH-200; LMD-X310ST MONITOR; OTV-S300 VISERA ELITE II VIDEO SYSTEM CENTER; UHI-4 HIGH FLOW INSUFFLATION UNIT