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

Model Number	MAJ-1026
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to olympus for evaluation.The device inspection confirmed the reported foreign substance in the water tank.When the subject device was connected and operated according to the instruction manual, there were no other abnormalities observed.The lot number of the device was not provided.The investigation is ongoing; therefore, a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
The user facility reported that during pre-use inspection of the subject device which had just been delivered, foreign matter was found in the tank of the device.The foreign matter was thought to possibly be a piece of plastic derived from the product.There was no impact on the intended procedure, which was completed using a similar device.There was no report of patient/user harm or injury due to the event.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information based on the legal manufacturer¿s investigation.Based on further investigation conducted by the legal manufacturer, it was reported that there was evidence of chemical damage on the device, and residue inside the device was not confirmed to be a foreign substance, as it is part of the product.Since no specific lot number was provided, no dhr review was performed.A review of the complaint database showed no other similar complaints were reported.The reported phenomenon was attributed to user handling.

• Brand Name: WATER CONTAINER (CONTAINER)
• Common Device Name: 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: 13766593
• Report Number: 8010047-2022-04423
• Device Sequence Number: 3967045
• Product Code: FET
• UDI-Device Identifier: 04953170079238
• UDI-Public: 04953170079238
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2022

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: MAJ-1026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2022
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 04/28/2022
• 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