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

Model Number PCF-H290DL

Device Problems No Display/Image (1183); Image Display Error/Artifact (1304)

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

Event Date 02/21/2024

Event Type  malfunction  

Manufacturer Narrative

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 was identified.The device was returned, and the evaluation found no additional reportable malfunctions other than those mentioned in b5.During initial inspection of the device, error code e315 unsupported scope was evident.Image was not present when the endoscope was connected and switched on.Error code e315 was displayed on the screen, the plug body was dismantled, the moisture indicator had been triggered.Quality trend analysis has shown that fluid inside the plug body can result in intermittent image issues temporarily affecting the video image and other electrical functionality.The most likely cause of fluid ingress is during the manual leak check or cleaning process and is therefore typically attributed to user handling.The suggested event is detectable and preventable by handling the scope in accordance with the following sections of the instructions for use: important information ¿ please read before use ¦precautions: caution turn the video system center on only when the endoscope connector is connected to the light source.In particular, confirm that the video system center is off before connecting or disconnecting the endoscope connector.Failure to do so can result in equipment damage, including destruction of the image sensor.¦precautions for disappeared or frozen endoscopic image: warning follow the precautions given below.Otherwise, the endoscopic image may disappear unexpectedly or the frozen image may not be restored during the examination.3.8 inspection of the endoscopic system ¦inspection of the endoscopic image confirm that the wli and nbi endoscopic images (except bf-mp290f) are normal.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 section 5.3, ¿withdrawal of the endoscope with an irregularity¿.Olympus will continue to monitor the field performance of this device.

Event Description

It was observed that during the device evaluation, the colonovideoscope exhibited error code 315 unsupported scope and compromised image.There were no reports of patient involvement.

• 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18923452
• MDR Text Key: 337896838
• Report Number: 9610595-2024-05705
• 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,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PCF-H290DL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2016
• 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