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

Model Number GIF-XP260

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 12/09/2022

Event Type  malfunction  

Manufacturer Narrative

The customer provided additional information regarding disinfection procedure that was followed onsite.Elapsed days and number of uses since last disinfectant replacement was 13 days, 13 times.The aceside concentration was not checked at every usage.Aceside checker was not owned by facility.Reason for not replacing aceside was reported as dealer's forgetfulness.Confirmation result of scopes reprocessed with antiseptic solution for which aceside concentration cannot be guaranteed was requested; however, it was unknown.The device will not be returned.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 disinfectant solution could not be set in the reprocessor and the disinfectant bottle tray lock could not be released.Error e99 occurred after release.The facility nurse was advised to check the aceside concentration and it was noted that the aceside check was not performed.The company representative informed the facility that the aceside concentration need to be checked at every usage.This report is being submitted to capture the complaint on scope that have been reprocessed with a disinfectant whose aceside concentration could not be guaranteed.There were no reports of patient harm associated with the event.Patient identifier (b)(6) captures complaint on the reprocessor (model : oer-4, model description : endoscope reprocessor, serial no.(b)(4).

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, the root cause of the event was unable to be identified.The subject device was not returned to olympus; therefore, the reported event could not be confirmed.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA 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 (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: 16111571
• MDR Text Key: 306808043
• Report Number: 9610595-2023-00266
• Device Sequence Number: 1
• Product Code: FDS
• 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,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-XP260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2006
• 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: OER-4 ENDOSCOPE REPROCESSOR (SERIAL NO. (B)(6).