MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. WATER CONTAINER

Model Number	MAJ-902
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Olympus medical systems corp.(omsc) was informed from the user that during preparation for unspecified procedure using the subject device in combination with the video processor cv-290 (patient was not under anesthesia), it was found that there was rust around the gas tube connector of the lid of the subject device.The user replaced the subject device to another similar device to complete the intended procedure.There was no report of patient injury associated with this event.
Additional Manufacturer Narrative
The subject device has not been returned to omsc for evaluation but was returned to olympus (b)(4).Olympus (b)(4) checked the subject device and found the following.- there were oxidation traces on the metal tip surfaces at both ends of the tube.- there were oxidation traces on the surface and inner wall of the metal joint outside the lid.- there was no oxidation trace on the surface and inner wall of the metal joint inside the lid.- there were traces of likely oxide residues on the surface of the outer package and instruction manual.In addition, olympus (b)(4) surmised that these phenomena were not due to quality problems of the subject device, but due to the high humidity in the storage environment or long-term contact with oxides.The exact cause has been under investigation.Therefore, the exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.The subject device was returned to olympus china.Olympus medical systems corp.(omsc) reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The subject device had been manufactured on october 2020.The exact cause of the reported phenomenon could not be conclusively determined based upon the information from olympus china.If additional information is received, this report will be supplemented.

• Brand Name: WATER CONTAINER
• Common Device Name: WATER CONTAINER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12561609
• Report Number: 8010047-2021-12572
• Device Sequence Number: 13839632
• Product Code: FDF
• UDI-Device Identifier: 04953170022937
• UDI-Public: 04953170022937
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2021

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
• Device Model Number: MAJ-902
• Device Lot Number: 0XR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2021
• Supplement Date Received by Manufacturer: 11/26/2021
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 12/23/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown