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

Model Number OER-4

Device Problem Failure to Disinfect (1175)

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

Event Date 09/25/2022

Event Type  malfunction  

Event Description

The olympus employee reported that while performing general maintenance on the endoscope reprocessor, it was discovered that the disinfectant used in the device had not been replaced for 89 days.It was also presumed that a concentration had not been done every time, prior to use.The reprocessor had only been used to clean non-olympus scopes, and there were no reports of health damage associated with the event.This mdr is being submitted to capture the reportable malfunctions found during the device evaluation.

Manufacturer Narrative

The device was evaluated, and it was found that the disinfectant solution used in the device was not replaced for a long time.Additionally, the device was used without checking disinfectant concentration.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

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 disinfectant not being replaced could not be determined.It is possible that there was unawareness of measuring the acecide concentration led to using the device without checking the concentration of the disinfectant solution., which may have also caused unawareness of the acecide's replacement timing, which may have resulted in the long-term usage.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿when reprocessing an endoscope, please always use an acecide checker or a portable concentration checker to check that the disinfectant solution is at an effective concentration.Please be sure to replace the disinfectant solution before the disinfectant effect disappears.If this check is not performed, the disinfection process may be ineffective.¿ 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; odakura, nishigo-mura,; 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: 15652271
• MDR Text Key: 303647505
• Report Number: 9610595-2022-03186
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2022

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2022
• Initial Date FDA Received: 10/21/2022
• Supplement Dates Manufacturer Received: 10/28/2022
• Supplement Dates FDA Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2021
• 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
• Treatment: THIRD PARTY SCOPE