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

Model Number	MAJ-207
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer, during a therapeutic bronchoscopy procedure, the suction valve would come loose from the bronchoscopes at the slightest movement.Another endoscope was tried with the valve, however, the issue remained.The rubber ring was not left in the bronchoscope.The intended procedure was completed similar device and no surgical delay.No patient harm reported.
Additional Manufacturer Narrative
The subject device referenced in this report was not returned for evaluation, therefore the device evaluation could not be completed at this time.The exact cause of the reported event could not be conclusively determined at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.Additional information was requested from the reporter.A supplemental report will be submitted should additional information be made available.
Event or Problem Description
It was reported by the customer, during a therapeutic bronchoscopy procedure, the suction valve would come loose from the bronchoscopes at the slightest movement.Another endoscope was tried with the valve, however, the issue remained.The rubber ring was not left in the bronchoscope.The intended procedure was completed similar device and no surgical delay.No patient harm reported.
Additional Manufacturer Narrative
The subject device referenced in this report was not returned for evaluation, therefore the device evaluation could not be completed at this time.The exact cause of the reported event could not be conclusively determined at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.Additional information was requested from the reporter.A supplemental report will be submitted should additional information be made available.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record and device manufacture date could not be completed as the device lot number is unknown.Based on the results of the legal manufacturer's investigation, it was surmised that the reported suction valves are within standards, but the loose torque was found to be close to the tolerance limit due to variability in molding.Loosening torque was improved and implemented from lot h1701.Olympus will continue to monitor field performance for this device.

• 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 ; 426425177
• MDR Report Key: 13018050
• Report Number: 8010047-2021-16252
• Device Sequence Number: 14680450
• Product Code: FAJ
• UDI-Device Identifier: 04953170063428
• UDI-Public: 04953170063428
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K993041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2022

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-207
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• 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: 11/23/2021
• Supplement Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 02/28/2022
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BRONCHOSCOPES, MODELS # UNKNOWN; BRONCHOSCOPES, MODELS # UNKNOWN.
• Patient Sex: Unknown