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

Model Number	MH-974
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.The device history record was unable to be reviewed for this device since the serial/ lot 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 reported issue could not be determined.We presumed that there was a difference in recognition on handling or reprocessing steps between olympus recommendation and the user.Olympus expert staff has already conducted training on proper reprocessing for the user.User can prevent the suggested event by following the instructions for use (ifu): when using this product, please follow the instruction manual (a4 size, vertical) of the endoscope on which this product is mounted or whose standard set includes this product.Note that some of the products listed in this access information sheet may not be available in some areas.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported the washing tube was sometimes hooked up to the scope then attached to the scope buddy to the washing tube to clean the tube and scope.A field service technician informed to confirm with medivator that the scope buddy was able to be used with the washing tube and if hooking the two up is correct or if medivator states they can't use the scope buddy and it needs to be manually cleaned.There were no reports of patient harm or injury.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: WASHING TUBE
• Common Device Name: WASHING TUBE
• 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: 19143109
• Report Number: 9610595-2024-08259
• Device Sequence Number: 7406681
• Product Code: ITX
• UDI-Device Identifier: 04953170071362
• UDI-Public: 04953170071362
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K093395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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: MH-974
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown