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 08/15/2022

Event Type  malfunction  

Manufacturer Narrative

Additional information was requested from the customer regarding the details of the reported event is pending.The investigation is ongoing; therefore, the root cause of the reported phenomenon cannot be determined at this time.However, if additional information becomes available this medical device report will be supplemented accordingly.

Event Description

Olympus (oj) was informed by the nurse at the user facility that error e99 (expired disinfectant) occurs during cleaning and disinfecting.The acecide check was not performed at all.The last exchange date was on august 2, 2022 (16 days have passed) and the number of times of use is small.No death, injury or harm has been reported to olympus.

Manufacturer Narrative

This supplemental report was submitted to provide additional details regarding the event and the legal manufacturer¿s investigation results.Since the last exchange, the accecide was last used on (b)(6) 2022.It was used 15 times in 7 days (unknown if concentration was checked) and was not used after that until (b)(6) 2022.The customer confirmed no adverse outcome was reported.Olympus further explained to the customer the characteristics of the accecide and how to check the concentration.Olympus field service inspected the machine for any abnormality in the main body of the washer and no abnormality was observed.The device history records (dhr) was reviewed and it was confirmed that the device met standards at the time of shipment.No repair history for the machine was confirmed in the past year.The investigation by the legal manufacturer determined that there is no design, manufacturing or material related cause for the reported e99 error code.Error code e99 is notified when the disinfectant solution is used more than 45 times or for more than 14 days.Due to information from the facility, it was reported that disinfectant solution was used for 15 days.Therefore, it is presumed that error code e99 occurred since the above met the notification condition.The event may have been caused by the user¿s wrong management method of disinfectant solution.To mitigate patient or user health hazard, the oer-4 operation manual describes ¿3.9 checking the disinfectant solution concentration level¿ regarding check of disinfectant solution concentration level as below.We judge the suggested event can be prevented by its implementation.3.9 checking the disinfectant solution concentration level.On reprocessing an endoscope, 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.

• 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: 15395197
• MDR Text Key: 305821970
• Report Number: 9610595-2022-01706
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/10/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/15/2022
• Initial Date FDA Received: 09/09/2022
• Supplement Dates Manufacturer Received: 09/14/2022
• Supplement Dates FDA Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2016
• 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