MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SUCTION VALVE

Model Number	MAJ-207
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to the original equipment manufacturer (oem).The device was tested/inspected using an olympus test scope and suction kit; the subject device worked appropriately with satisfactory suction capacity.The oem performed the device history records for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.The oem confirmed that the device worked as expected without any problems.The reported failure was likely caused by a loose connection of the devices and or defect of other devices.The oem will continue to monitor the field performance of this device.
Event or Problem Description
The user facility informed olympus ((b)(6)) that some of the suction valves reportedly have no suction during testing with a 180 series type bronchoscope.No patient involvement was reported.This report is for 1 of 2 suction valves.
Additional Manufacturer Narrative
This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.Correction to g3 of the initial medwatch.The aware date should be 31-mar-2021.

• Brand Name: SUCTION VALVE
• Common Device Name: SUCTION 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 ; 81426423174
• MDR Report Key: 12112151
• Report Number: 8010047-2021-08363
• Device Sequence Number: 3800285
• Product Code: KGE
• UDI-Device Identifier: 04953170063428
• UDI-Public: 04953170063428
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K993041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2022

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-207
• Device Lot Number: H0619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• 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: 06/17/2021
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2020
• 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: OLYMPUS, BF-1T180 BRONCHO-VIDEOSCOPE
• Patient Sex: Unknown