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)

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 a non-target scope connection (error code e315) due to corrosion on endoscope connector.There were no reports of patient involvement.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation and associated h6 coding.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 that the following led to the malfunction: water invaded the scope connector during user handling causing the corrosion of the scope connector and the error message e315 to be displayed.The event can be detected and prevented by following the instructions: 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.

• 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: 18826855
• MDR Text Key: 337072991
• Report Number: 9610595-2024-04440
• 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: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• 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: 02/20/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2014
• 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