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

Model Number CF-HQ290ZI

Device Problems Corroded (1131); Communication or Transmission Problem (2896); Failure to Clean Adequately (4048)

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

Event Type  malfunction  

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.

Event Description

It was observed that during the device evaluation, the colonovideoscope exhibited an error 315 (unsupported scope error) due to corrosion on the connector.There was no patient involvement.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.New information added to the following fields: h6.Corrected field: h6 - medical device problem code.A review of device history record and historical complaints analysis was conducted and no deviations that could have caused or contributed to the reported issues was identified.Based on the results of the investigation a definitive root cause could not be determined.However it is likely that unsupported scope connection error message (e315) occurred due to stress of repeated use, external factors or handling of the device, the image sensor unit was damaged such as disconnection or parts mounted on the electrical circuit board such as integrated circuit chips and capacitors were broken, which may have resulted in the subject event.The event can be prevented by following the instructions for use: "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." the condition can be detected by following the device instructions for use (ifu): "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.

• 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: 18728261
• MDR Text Key: 336633005
• Report Number: 9610595-2024-03431
• 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
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2024
• 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: 01/25/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2020
• 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