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

Model Number GIF-HQ290

Device Problems Material Deformation (2976); Failure to Clean Adequately (4048)

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

Event Date 10/11/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The nozzle was clogging with foreign material.The foreign material was unable to be removed, preventing identification.The investigation is ongoing.A supplemental will be submitted on completion of investigation or if any additional information is available.

Event Description

The customer reported to olympus, the nozzle of the videoscope was deformed during reprocessing, which had been attributed to the reprocessing/cleaning of the device.The intended procedure was completed with the same device.There were no reports of patient harm associated with this event.

Manufacturer Narrative

This report is being submitted for additional information provided by the customer.The investigation is ongoing.A supplemental will be submitted on completion of investigation or if additional information is available.

Event Description

It was further reported, before the operation it was found that the shape of the nozzle water column was divergent which was not enough to clean the lens surface and it was replaced with another endoscope.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to correct h6 (problem code) correction to h6: material deformation should be removed from the h6 problem code as it was clarified that the user¿s finding was insufficient water contact with the objective lens due to the shape of the nozzle's water column.The water column was divergent which was later confirmed during the evaluation and found to be caused by a clogged nozzle.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 was confirmed that the nozzle was clogged with foreign material, however, the specific material could not be identified and the cause for the clog could not be specified.The nozzle was not deformed or broken and there were no reported deviations from the instructions for use (ifu).Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15769294
• MDR Text Key: 307882220
• Report Number: 9610595-2022-03764
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-HQ290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2018
• 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-290.