MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. AIR/WATER VALVE

Model Number	MH-438
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	04/20/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The subject device in this report has not been returned to olympus medical systems corp.(omsc) for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
Event or Problem Description
A patient died after an endoscopic procedure for endoscopic submucosal dissection (esd) with the subject device.The user facility requested olympus to find out if the device has any problems.The user facility did not provide other detailed information.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) investigated the subject device.However, the exact cause of the reported event could not be conclusively determined.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.If additional information becomes available, this report will be supplemented.

• Brand Name: AIR/WATER VALVE
• Common Device Name: AIR/WATER VALVE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10104491
• Report Number: 8010047-2020-03017
• Device Sequence Number: 886759
• Product Code: FDS
• UDI-Device Identifier: 04953170071249
• UDI-Public: 04953170071249
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MH-438
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/08/2020
• Supplement Date Received by Manufacturer: 06/12/2020
• Initial Report FDA Received Date: 06/01/2020
• Supplement Report FDA Received Date: 07/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death