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

Model Number OER-4

Device Problem Misassembly During Maintenance/Repair (4054)

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

Event Date 11/27/2022

Event Type  malfunction  

Manufacturer Narrative

Reports are being submitted on the oer-4 aer and the scope.Please refer to the following reports: patient identifier of (b)(6) is related to model number: oer-4, serial number: (b)(4).Patient identifier of (b)(6) is related to model number: gif-h290z, serial number: (b)(4).This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

The customer reported that the main board of the oer-4 automatic endoscope reprocessor (aer) was recently replaced; however, after the replacement, the maintenance tool could not be connected to the aer.The issue was resolved after reinstalling the oer-4 program.When reviewing the work, the customer found that a board for the oer-3 was used.Between (b)(6) 2022 and (b)(6) 2022, the aer was used with the oer-3 board.No errors occurred and it was unclear whether the aer worked properly and cleaned in the correct process.Multiple scopes, including the evis lucera elite gastrointestinal videoscope, were reprocessed using the aer during this time.There was no reported patient harm or impact due to this event.

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, it is likely that the cause of the event was due to the installation of an incorrect printed circuit board.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 (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: 16021150
• MDR Text Key: 308550913
• Report Number: 9610595-2022-05842
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 04/04/2023
• Supplement Dates FDA Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2014
• 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