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

Model Number	MAJ-521
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the air supply was insufficient and water remained on the lens surface.It was also reported that the rubber part appeared to be missing.The reported issue occurred while preparing the subject device for use during a diagnostic colonoscopy procedure.The intended procedure was completed using another device.There was no patient or user injury reported due to the event.The device was returned to an olympus service center for evaluation.Upon inspection and testing of the returned device, it was observed the valve was clogged with foreign material.This report is being submitted for the malfunction found during evaluation of the device (foreign material in valve).
Additional Manufacturer Narrative
During inspection and testing, packaging damage was confirmed.The device history record was not able to be reviewed for the subject device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the legal manufacturer's investigation, it is likely the foreign material was derived from silicone-based substances such as watertight packing, the products used in combination with the scope (e.G., buttons, injection tube, cleaning tube, deterioration of water supply tank, etc.), and peripheral equipment.It is possible that insufficient air supply and damaged packing may have caused foreign matter to reach the button vents.However, a definitive root cause could not be determined.Olympus will continue to monitor field performance for this device.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.

• Brand Name: GAS/WATER VALVE
• Common Device Name: GAS/WATER VALVE
• 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: 14741378
• Report Number: 8010047-2022-10336
• Device Sequence Number: 17837080
• Product Code: FET
• UDI-Device Identifier: 04953170071478
• UDI-Public: 04953170071478
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/19/2022

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-521
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2022
• 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: 04/18/2022
• Initial Report FDA Received Date: 06/19/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PCF-PQ260L EVIS LUCERA COLONOVIDEOSCOPE
• Patient Sex: Unknown