MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. WASHING TUBE

Model Number	MH-974
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has not been returned to olympus for evaluation.A supplemental report will be submitted, if additional or significant information becomes available at a later time.
Event or Problem Description
Olympus medical systems corp.(omsc) was informed from the user that during the preparation for use, it was found that there was rust between the tube of the subject device and the joint at the connecting end of the subject device.The user think that the rust may be a result due to the fact that the subject device is also connected to a saline water bottle which is pumped through our irrigation machine.Other detailed information was not provided.There was no report of patient injury associated with the event.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.The subject device was not returned to olympus for evaluation.Olympus medical systems corp.(omsc) could not review the device history record of the subject device since the lot number of the subject device is unknown.Omsc ship out devices meeting to the specifications.The exact cause of this event could not be conclusively determined.Omsc surmised that the reported phenomenon occurred since the subject device was inadequately dried after reprocessing.

• Brand Name: WASHING TUBE
• Common Device Name: WASHING TUBE
• 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: 12420027
• Report Number: 8010047-2021-11198
• Device Sequence Number: 3593640
• Product Code: ITX
• UDI-Device Identifier: 04953170071362
• UDI-Public: 04953170071362
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K093395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2021

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: MH-974
• 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: 08/17/2021
• Supplement Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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