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

Model Number CF-HQ290L

Device Problems Image Display Error/Artifact (1304); Communication or Transmission Problem (2896)

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

Event Date 06/06/2023

Event Type  malfunction  

Event Description

It was reported to olympus by a customer care coordinator, that a colonovideoscope had an e315 error failure during a procedure.There was no clinical impact but there was a 10-minute delay changing over the scope.The procedure was completed successfully using another scope.There was no patient injury or adverse event reported to olympus.

Manufacturer Narrative

The device was returned to olympus for evaluation and repair.During the evaluation, the light cover glasses were found chipped and the adhesive was worn.The optical cover glass was chipped and the adhesive was worn.The distal end adhesive was found lifting and the switch condition was worn.The investigation is still in progress; therefore, the root cause of the reported defect cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.In general, the customer is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.Olympus will continue to monitor the field performance of this device.A manufacturing and quality control review was performed for the affected serial number without showing any non-conformities or deviations regarding the described issues.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's (lm) final investigation.Updated fields: d9, h6 and h10.The e1 "telephone number" was corrected due to incorrect country code.The g2 and h6 "medical device problem code" fields were corrected based on information available at the time of the initial report submission.Based on the results of the investigation, water invaded the scope connector during user handling causing the electrical components to be damaged and the error message e315 was displayed.The suggested event is detectable and preventable by handling the scope in accordance with the following sections of 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.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: 17275037
• MDR Text Key: 318768796
• Report Number: 9610595-2023-09803
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CF-HQ290L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2015
• 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