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

Model Number MH-974

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2021

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 279624742
• Report Number: 8010047-2021-11198
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170071362
• UDI-Public: 04953170071362
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• 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
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1