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

Model Number CF-H290L

Device Problems Mechanical Problem (1384); Communication or Transmission Problem (2896)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the evaluation found the following: the adhesive on the bending section cover was detached, the light guide lens was broken, the light guide bundle was abnormal, the gap on the up/down knob and the angulation in the up direction was out of standard value due to a worn angle wire, there was corrosion from the plug unit and scope connector unit due to leakage, the scope cover was deformed, switch 3 had a scratch, the suction cylinder was peeling off, the insulation resistance value of the distal end was out of standard value due to a scratch on the plastic distal end cover, the angulation was low, and the objective lens and light guide lens had a chip.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus, that the colonovideoscope had an e315 incompatible scope error and the angulation was reduced.The issue was found during preparation for use for an unspecified diagnostic procedure.The device was inspected before usage and there was no delay in procedure.The intended procedure was completed using a similar device.There were no reports of patient harm.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of device history record and historical complaints analysis was conducted and no deviations that could have caused or contributed to the reported issues was identified.Based on the results of the investigation a definitive root cause could not be determined.However it is likely that error message e315 was due to internal electronic parts had abnormality by the water invasion of scope connector.The event can be prevented by following the instructions for use which state: 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: 18415068
• MDR Text Key: 331904485
• Report Number: 9610595-2023-20380
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CF-H290L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2017
• 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