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

Model Number CF-H290I

Device Problems Corroded (1131); Communication or Transmission Problem (2896)

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

Event Type  malfunction  

Event Description

The customer reported to olympus that there was an e315 scope error while using the evis lucera elite colonovideoscope.There was no procedural delay, and the procedure was completed with a similar device.There was no patient harm associated with the event.

Manufacturer Narrative

The device was returned and evaluated, and the customer¿s allegation was confirmed due to corrosion of the plug unit.Additional evaluation findings include the following: the gap of the up/down knob was out of standards due to wear of the angle wire, low angulation was evident due to stretched wires, the water amount was out of standards due to deformation of the nozzle, there was a crease at the charge-coupled device lens, the light guide (lg) lens was broken, the distal end had scratches and dents, the adhesive part of the of the bending rubber was broken, the bending section cover¿s glue was discolored, there was a crease at the connecting tube protector, there was a pin hole in switch button one (1), there was a crease at the universal cord, the suction cylinder was deformed, the air/water cylinder was deformed, and corrosion was evident on the following components due to leakage: control part, scope connector cover, scope connector and scope connector cover unit.The investigation is ongoing and follow-up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This report is being supplemented to provide additional information provided by the customer: b5: the issue occurred during preparation for use for a diagnostic procedure.

Event Description

The issue occurred during preparation for use for a diagnostic procedure.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to correct e2/e3.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause could not be determined.It is likely water invaded the scope connector while the user was handling the device, which led to an abnormality in the electrical parts, specifically corrosion to the plug unit, and resulted in the displayed error message (e315).The event can be detected and prevented by following the instructions for use (ifu) which state: "·inspection of the endoscopic image" "·when attaching the connector cap of the leakage tester (mb-155) to the venting connector of the endoscope, make sure that both the connector cap and the venting connector are thoroughly dry.Water on the surface of either component may enter the endoscope and could cause endoscope damage.·do not attach/detach the leakage tester while the endoscope is immersed.Attaching/detaching under water could allow the water to enter the endoscope, resulting in endoscope 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: 16064717
• MDR Text Key: 308528497
• Report Number: 9610595-2022-06222
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CF-H290I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2013
• 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