MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE

Model Number LTF-190-10-3D

Device Problem Image Display Error/Artifact (1304)

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

Event Date 11/16/2022

Event Type  malfunction  

Event Description

The olympus field service engineer reported (on behalf of the customer) that there was a 3d image flashing issue on the endoeye flex 3d deflectable videoscope.The issue occurred after the procedure was completed (with the same device) and there was no patient harm associated with the event.

Manufacturer Narrative

The device is not expected to be returned for repair; therefore, the customer¿s allegation is unable to be confirmed.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, device evaluation, and corrections to e2 and e3.Please see updates to e2, e3, d8, d9, h3, h6, and h10.The device was returned to olympus for inspection, and the customer's complaint was not confirmed.Additionally, the repair center found there was a pinhole on the universal cord and the water tightness was lost.The bending section cover was scratched, the control unit was deformed, and there were broken wires in the bending section.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 7 years since the subject device was manufactured.The 3d image flashing issue was unable to be reproduced during the device evaluation; therefore, a final root cause was unable to be identified.However, based on the results of the investigation, probable causes for the temporary event include: a) charged coupled device (ccd) unit or internal board of video connector was temporarily broken due to moisture that invaded device from leaked location.B) ccd cable inside was damaged by physical stress applied to the bending section.C) ccd unit temporarily failed by the following device handling.- video connector was inserted / pulled while system was powered on.- electrification was turned on while dust, dirt, moisture, or the like adhered to video connector contacts.D) abnormality of video system center or cable used at user facility.The following is included in the instructions for use: ¿important information ¿ please read before use: dangers, warnings, and cautions: - do not insert the video connector while the electrical contacts are wet and/or dirty.This may result in an electric shock, causing severe damage to the endoscope and compromising patient and/or operator safety.- turn the video system center on only when the video connector is connected to the video system center.In particular, confirm that the video system center is off before connecting or disconnecting the video connector.Failure to do so can result in equipment damage, including destruction of the image sensor.Important information ¿ please read before use: precautions for disappeared or frozen endoscopic image: - do not bend, hit, pull, or twist the insertion section, bending section, control section, universal cord, video cable, video connectors, and light guide connector.The endoscope may be damaged, and water leakage and/or breakage of internal parts like the image sensor cable can result.- before connecting the video connector to the video system center, confirm that the video connector, including the electrical contacts, is completely dry and clean.If the endoscope is used with the electrical contacts wet and/or dirty, the endoscope and video system center may malfunction.- if air bubbles emerge from the endoscope continuously during leakage test, do not use the endoscope.Water may enter the endoscope and cause a short circuit.This may result in breakage of the switch and image sensor.¿ olympus will continue to monitor field performance for this device.

• Brand Name: ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE
• Type of Device: FLEX 3D 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: 15971909
• MDR Text Key: 308531094
• Report Number: 9610595-2022-05350
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170340710
• UDI-Public: 04953170340710
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K123365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2023

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-190-10-3D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• 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: 01/27/2023
• Supplement Dates FDA Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2015
• 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