MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS LUCERA ELITE COLONOVIDEOSCOPE

Model Number CF-HQ290ZI

Device Problem Corroded (1131)

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

Event Type  malfunction  

Event Description

It was observed that during the device evaluation, the colonovideoscope had an e315 scope error.There were no reports of patient involvement.

Manufacturer Narrative

The device was returned and the evaluation found no reportable malfunctions aside from the allegation reported in b5.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected fields: h4.Additional information added to field h6.A review of device history record and historical complaints analysis was conducted and no deviations that could have caused or contributed to the reported issue were identified.Based on the results of the investigation, it is likely the following led to the malfunction that the event occurred due to the damage of image sensor unit(disconnection, etc.) or breakage of the mounting components (ic chip, capacitor, etc.) of the electric board due to use stress, external factors, or handling.Chapter 3 preparation and inspection the equipment prepared before using this endoscope and procedures for inspection of the endoscope and equipment are described in this chapter.3.1 the workflow of preparation and inspection the workflow of preparation and inspection is shown below.Before each case, prepare and inspect this endoscope as instructed below.Inspect other equipment to be used with this endoscope as instructed in their respective instruction manuals.Should any irregularity be observed after inspection, follow the instructions as described in chapter 5, ¿troubleshooting¿.If the endoscope malfunctions, do not use it.Return it to olympus for repair as described in section 5.4, ¿returning the endoscope for repair¿.Warning ¿ using an endoscope that is not functioning properly may compromise patient or operator safety and may result in more severe equipment damage.Chapter 5 troubleshooting the countermeasures against troubles are described in this chapter.5.1 troubleshooting if any irregularity is observed during the inspection described in chapter 3, ¿preparation and inspection¿, do not use the endoscope and solve the problem as described in section 5.2, ¿troubleshooting guide¿.If the problem still cannot be resolved, send the endoscope to olympus for repair as described in section 5.4, ¿returning the endoscope for repair¿.Also, should any irregularity be observed while using the endoscope, stop using it immediately and withdraw the endoscope from the patient as described in section 5.3, ¿withdrawal of the endoscope with an irregularity¿.Warning ¿ never use the endoscope on a patient if an irregularity is observed.Damage or an irregularity in the endoscope may compromise patient or user safety and may result in more severe equipment damage.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented as the legal manufacturer re-evaluated the subject device and provided an additional investigation.The device was re-evaluated by olympus, and the reportable malfunction was not confirmed.Based on the results of the investigation, although the e315 error code was unable to be duplicated, it was confirmed that there was evidence of water invasion inside of the scope connector.It is likely that the cv-1500 side detected an abnormalities and reported the e315 error due to moisture adhering to the printed circuit board built into the scope connector due to flooding, which caused a temporary continuity failure.In addition, deposits that appeared to be white chemical residue were found on the check valve of the venting connector, so it is likely that water may have entered the product through the venting connector.Although it is difficult to pinpoint the cause since there is no information regarding user handling, attaching the eog cap or water leak test.Water droplets attached to the surface of the venting connector may have caused moisture to enter the scope connector.A definitive root cause could not be established.The event can be detected/prevented by following the instructions for use which state: it was confirmed that the operation manual for gif/cf/pcf-290 series ¿chapter 3 preparation and inspection 3.8 inspection of the endoscopic system¿ describes how to inspect for the suggested event1.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA ELITE COLONOVIDEOSCOPE
• Type of Device: COLONOVIDEOSCOPE
• 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: 18780985
• MDR Text Key: 336970592
• Report Number: 9610595-2024-03973
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2024

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: Other
• Device Model Number: CF-HQ290ZI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 03/08/2024; 05/13/2024
• Supplement Dates FDA Received: 03/20/2024; 05/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2016
• 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