MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. ENDOSCOPE REPROCESSOR

Model Number OER-5

Device Problem Device Handling Problem (3265)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(6).There are total 9 devices associated with this event (four automatic endoscopy reprocessors (aers), four water filters, and one unknown scope).These devices are captured in medwatches with patient identifiers as below: patient identifier: (b)(6), model # oer-5 (aer), serial # (b)(4); (b)(6) oer-5 (aer), (b)(4) ;(b)(6) oer-6 (aer), (b)(4); (b)(6) oer-6 (aer), (b)(4); (b)(6) maj-2317 (water filter), (b)(6) maj-2317 (water filter), (b)(6) maj-2317(water filter), (b)(6) maj-2317 (water filter), (b)(6) cf-h290i, representing the unknown scope.This medwatch is for the patient identifier (b)(6).This device is not sold in the us but a similar device is.The device is not returned, as such a definitive root cause of the reported complaint cannot be determined at this time.This event is under investigation.A supplemental report will be submitted upon completion of the investigation or upon receiving additional information.

Event Description

There are four automatic endoscopy reprocessors (aers) at the facility impacted.There are also four water filters, one for each aer, associated with this event.As reported for this event by the facility, the water supply lines to the device were disinfected on the day the acecide disinfectant of the device was changed.The normal usage for of the acecide disinfectant for the facility was 27 times before the acecide was required to be changed.The facility did not do a check for the disinfectant concentration at every use of the device as recommended by the instructions for use.However, a disinfectant concentration check was performed for one of the aer devices the day after the disinfection of the water supply line, though the 27 uses were not completed, and the device failed the concentration test.There is a possibility that a scope was reprocessed with reduced concentration of acecide disinfectant and used.In addition, it was found that this was the first time the facility disinfected the water supply line since the aer devices were delivered approximately eight months before the event; the water filters of all four aers also had not been replaced since the first use of the device.The facility does not have any incident of harm reported to any patient or persons.The facility has now been made aware that the acecide concentration check needs to be performed for every use.

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 event likely occurred due to the user's lack of awareness and mistakes in the management method of disinfecting and replacing water filters.Information is stated in the oer-5 instructions for use (ifu) which may have prevented the event by following sections 3.11 checking the disinfectant solution concentration level, 7.3 replacing the water filter and 7.4 disinfecting the water supply piping.Olympus will continue to monitor field performance for this device.

• Brand Name: ENDOSCOPE REPROCESSOR
• Type of Device: ENDOSCOPE REPROCESSOR
• 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: 15115438
• MDR Text Key: 304817587
• Report Number: 9610595-2022-00346
• Device Sequence Number: 1
• Product Code: FEB
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2021
• 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