MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. WASHING CASE

Model Number	MAJ-2121
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation as the field service engineer (fse) was at the facility.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The field service engineer (fse) reported to olympus, the washing case was being used off label.The lids of the washing basin were removed from the washing basin cup and only three of the four lids could be found.It was reported that when reprocessing a single dilator with a scope, the dilator was connected by the orange connector d2 with a lure lock needle attached to the d2 connector.This connector is used to reprocess the maj-855 tubing and the aux channel of the scope.It was also noted that the maj-855 tubing was freely in the basin with no connection to high level disinfect.There was also connectors a1, b1, c1, d1 two sets freely being reprocessed at that time.There were no reports of patient involvement.The fse stopped the cycle and educated the staff and change nurse, advising that olympus does not validate dilators or freely placed items in the oer-elite.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Section e3 was corrected to align with section e2 in the initial report.The device history record was unable to be reviewed and the manufacturing date is unknown for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.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 when the user opened the washing case lid, unexpected force was applied and caused the lid to detach.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿make sure that the washing case (with a gray cover) for exclusive use with this reprocessor is attached.Also, check that the washing case is free of irregularity such as a crack or fissure.If any irregularity is found, do not use the washing case and contact olympus.¿ olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
New information has been added to section h4 which contains the device manufacturer date of july 20, 2022.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's device evaluation and investigation.Based on the results of the device evaluation, the reported event confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, a definitive root cause of the reported event could not be identified.However, it¿s likely the cause is related to the lid of the washing case being detached from the black rubber, and the user using the case in that status.Also, it¿s possible that when the user opened the lid of the washing case, unexpected force was applied such as pulling the chain at the black rubber and/or pushing the rubber obliquely/laterally, which caused the event.Note: once the rubber was detached, the lid may not have been attached properly to the rubber which led to it easily being detached.When the lid is detached, one must push the retained part of the rubber hard into the hole of the lid until the rubber is completely locked.Use of the lid without proper attachment of the rubber would cause the lid to detach.Olympus will continue to monitor field performance for this device.

• Brand Name: WASHING CASE
• Common Device Name: WASHING CASE
• 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: 17222603
• Report Number: 9610595-2023-09470
• Device Sequence Number: 17912957
• Product Code: FEB
• UDI-Device Identifier: 04953170404153
• UDI-Public: 04953170404153
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K190969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/06/2024

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
• Operator of Device: Health Professional
• Device Model Number: MAJ-2121
• Device Lot Number: 27A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2023
• Supplement Date Received by Manufacturer: 09/26/2023; 05/15/2024; 05/25/2024
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 09/28/2023; 05/15/2024; 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OER-ELITE - REPROCESSOR
• Patient Sex: Unknown