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

Model Number	MH-438
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.If additional information becomes available prior to the conclusion of the investigation, a supplemental report will be filed.
Event or Problem Description
The customer reported that during a diagnostic endoscopy procedure, her olympus air/water valve began leaking.According to the initial reporter, the subject device was still used to complete the procedure without any patient harm noted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Section g2 was corrected to accurately identify the report source as a healthcare professional.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the leak could not be determined.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿confirm that the top hole of the air/water valve is not blocked.If the hole is blocked, air is fed continuously and patient pain, bleeding, and/or perforation can result.¿ olympus will continue to monitor field performance for this device.

• Brand Name: AIR/WATER VALVE
• Common Device Name: AIR/WATER VALVE
• 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: 15138214
• Report Number: 9610595-2022-00477
• Device Sequence Number: 5600866
• Product Code: FDS
• UDI-Device Identifier: 04953170071249
• UDI-Public: 04953170071249
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• PMA/510(K) Number: K051645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2022

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
• Operator of Device: Health Professional
• Device Model Number: MH-438
• Device Lot Number: 17A
• 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: 07/08/2022
• Supplement Date Received by Manufacturer: 11/24/2022
• Initial Report FDA Received Date: 08/01/2022
• Supplement Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2011
• 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