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

Model Number	MAJ-207
Medical Device Problem Codes	Product Quality Problem (1506); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has not yet been received for evaluation.The root cause of the issue is unknown at this time.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
As reported, at delivery acceptance during inspection, it was found the suction buttons were loose when installed on the scope and easy to fall off, it happened for all scopes.There is no patient involvement associated on this reported event.No user injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction to g2 to add foreign country.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it was concluded/assumed that the reported suction valves were within standard, but loosening torque was close to the tolerance limit due to variability in molding.In conclusion, a root cause could not be identified for this reported phenomenon.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: 13067624
• Report Number: 8010047-2021-16689
• Device Sequence Number: 17155802
• Product Code: FAJ
• UDI-Device Identifier: 04953170063428
• UDI-Public: 04953170063428
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2022

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-207
• Device Lot Number: H9Y12
• 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: 12/01/2021
• Supplement Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2019
• 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: BF-260.
• Patient Sex: Unknown