MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. GAS/WATER VALVE

Model Number	MAJ-2010
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was observed during the device inspection the gas/water valve¿s metal parts were corroded.There were no reports of patient involvement.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following fields: d8, h3, h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The manufacture date cannot be identified at this time since the serial/lot was not provided.Based on the investigation results, corrosion on the metal part, could not be identified.The root cause of the subject was unable to be specified.Presumably, as a result of confirmation of the actual device, the analysis of corrosion revealed a component of organic silicone and chloride.It is presumed that organic silicone may be derived from coating of lubricant.It can pose an obstacle to the valve function as described in the instruction manual.There is a past case that chloride was originated from a chloride component used in the facility such as medical solution for the non-olympus reprocessor, resulting in residue and corrosion.However, a definitive root cause could not be established.The events can be detected and prevented in accordance with the following sections of the instructions for instructions for use: ¿chapter 6, ¿cleaning, disinfection, and sterilization procedures¿ section 6.2, cleaning¿ describes how to inspect for the subject events.¿.Olympus will continue to monitor the field performance for this device.

• Brand Name: GAS/WATER VALVE
• Common Device Name: GAS/WATER VALVE
• 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: 20082241
• Report Number: 9610595-2024-17197
• Device Sequence Number: 7810995
• Product Code: FDF
• UDI-Device Identifier: 04953170437830
• UDI-Public: 04953170437830
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2024

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: Other
• Device Model Number: MAJ-2010
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 09/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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