MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. AW CHANNEL CLEANING ADAPTE

Model Number	MH-948
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Based on the results of the investigation, it is likely that the user¿s lack of understanding of instruction for use had caused the subject event.The instructions for use warns the prevention method associated with the event in: olympus endoscopes reprocessing manual chapter 3, ¿cleaning, disinfection and sterilization procedures¿ describes that mh-948 is not compatible for disinfection with acecide 6% disinfectant solution.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported the air/ water channel cleaning adapter was being reprocessed inappropriately because the product is not eligible for cleaning machines.The issue occurred during reprocessing.There were no reports of patient harm.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported the air/ water channel cleaning adapter exhibited inappropriate reprocessing.The issue occurred during reprocessing.There were no reports of patient harm.

• Brand Name: AW CHANNEL CLEANING ADAPTE
• Common Device Name: AW CHANNEL CLEANING ADAPTE
• 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: 20021121
• Report Number: 9610595-2024-16676
• Device Sequence Number: 15621808
• Product Code: FET
• UDI-Device Identifier: 04953170071355
• UDI-Public: 04953170071355
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K954451
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

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-948
• 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: 08/07/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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