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

Model Number GIF-XP260NS

Device Problems Improper or Incorrect Procedure or Method (2017); Failure to Clean Adequately (4048)

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

Event Date 12/05/2022

Event Type  malfunction  

Event Description

The customer reported to olympus, the facility owned endoscope reprocessor exhibited e01 error.The olympus customer information center (cic) was contacted by the facility.The problem was not resolved.During conversation, it was noted that the water filter of the reprocessor was not replaced since october 2019.The olympus staff visited the facility and explained the necessity and procedure of disinfection of each consumable and water supply pipe.It was also reported that there were no health hazards to patients.This report captures complaint on the scope (model: gif-xp260ns, model description: evis lucera gastrointestinal videoscope, serial no.(b)(4) that was in operation at the facility.The complaint regarding the reprocessor is captured in patient identifier (b)(6) (device: oer-4, model description: endoscope reprocessor, serial no.(b)(4)).Complaints on other impacted scopes captured in patient identifier: (b)(6) (device: cf-h290i, model description: evis lucera elite colonovideoscope, serial no.(b)(4)) patient identifier:(b)(6) (device: cf-q260ai, model description: evis lucera colonovideoscope, serial no.: (b)(4)) patient identifier: (b)(6) (device: gif-xp290n, model description: evis lucera elite gastrointestinal videoscope, serial no.(b)(4)).

Manufacturer Narrative

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.

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; however, it was determined that the event occurred due to improper handling by the user.Based on the information that the water filter has not been replaced since october 2019 (the period of non-replacement is more than 3 years), which is not recommended, the user does not fully understand the maintenance method of the equipment.The event can be prevented by following the instructions for use which is states in 7.2 replacing the water filter (maj-2318) "that it [water filter] should be replaced at least once a month." 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: 16085381
• MDR Text Key: 308422758
• Report Number: 9610595-2023-00015
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-XP260NS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2015
• 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 REPROCESSOR (SERIAL NO. (B)(4))