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

Model Number OER-4

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 01/12/2023

Event Type  malfunction  

Event Description

The customer reported an e99 error message occurred on automatic endoscope reprocessor (aer) during maintenance on january 12, 2022 and the aceside concentration had not been checked previously.When troubleshooting with customer service a week later, the customer discovered the concentration of the aceside was not checked since the error had occurred.The aer had been used to reprocess scopes.The number of cases was unknown.The aceside concentration was then checked to confirm the concentration was effective.Cleaning and disinfection was then carried out.The customer was instructed to check the aceside concentration before cleaning and disinfection every time.The customer noted the usual method of operating aceside at the facility was to replace it when the number of days used after preparation exceeded the number of days used by the facility (about every 14 days of operation).The aceside had reached day 15 when it was used without checking the concentration.The cause of the why the concentration was not checked was unknown.There was no reported patient harm or impact due to this event.

Manufacturer Narrative

Reports are being submitted on the aers and scopes that were reprocessed.Please refer to the following reports: patient identifier of (b)(6) is related to model number: cf-h290i, serial number: (b)(4).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-h290, serial number: (b)(4).Patient identifier of (b)(6) is related to model number: gif-q260, serial number: (b)(4).Patient identifier of (b)(6) is related to model number: oer-4, serial number: (b)(4).This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the approved 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, and since the device was not returned for evaluation, the definitive root cause of the reprocessing issue could not be determined.It is possible that the user made a mistake in managing the disinfectant solution.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: 16310629
• MDR Text Key: 308952870
• Report Number: 9610595-2023-01867
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2018
• 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