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

Model Number CF-H290I

Device Problems Contamination (1120); Electrical /Electronic Property Problem (1198); Moisture Damage (1405); Connection Problem (2900)

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

Event Date 05/17/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that the evis lucera elite colonovideoscope had e315 (untargeted scope connection) occurs due to corrosion of the scope connector during preparation for use, when the scope body is connected.The unknown procedure was completed using a similar device.There was no report of patient harm or user injury associated with this event.

Manufacturer Narrative

Establishment name: (b)(6) hospital.The device was returned to olympus for inspection, and the customer's allegation was confirmed.In addition, the following non-reportable malfunctions were found during device evaluation: due to wear of angle wire, bending angle in up direction does not meet the standard value, due to wear of angle wire, the play of up/down knob is out of the specification, adhesive on bending rubber has a crack and scratch, scope connector is dirty due to water leakage, scope identification is not displayed, objective lens has discoloration, image guide protector has a scratch, flexibility adjustment ring has a scratch, lock engagement lever has a scratch, up/down right/left knobs have a scratch, protector of universal cord on control section side has a scratch, scope connector cover unit has a scratch, switch box has a scratch, universal cord has discoloration and a scratch, and grip has a scratch.The investigation is on-going.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 based on the legal manufacturer's final investigation.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, a definitive root cause could not be established.Since the actual item was not sent to the legal manufacturer, it was not possible to specify the cause of the suggested event.However, the suggested phenomenon was presumed to have been caused by breakage or disconnecting of the image sensor unit due to stress of repeated use, external factors or handling, or failure of the parts mounted on the electrical circuit board such as the integrated circuit chip and capacitor.The operation manual describes how to inspect for the suggested event in ¿chapter 3 preparation and inspection, section 3.8 inspection of the endoscopic system¿ as below: "[inspection of the endoscopic image].1 observe the palm of your hand using the wli and nbi [white light imaging and narrow band imaging] endoscopic images.2 confirm that light is output from the endoscope¿s distal end.3 confirm that the wli and nbi endoscopic images are free from noise, blur, fog, or other irregularities.4 turn the up/down and right/left angulation control knobs slowly in each direction until they stop.5 confirm that the wli and nbi endoscopic images do not momentarily disappear or display any other irregularities." 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: 17123008
• MDR Text Key: 317253710
• Report Number: 9610595-2023-08825
• 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,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• 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: 05/18/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2022
• 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
• Treatment: CV-1500