MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT SINGLE USE SUCTION VALVE (STERILE)

Model Number	MAJ-209
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported the suction valve on the scope popped off.The suction valve was properly attached, but the coil/spring broke due to the suction line pulling the valve.The solution to the issue was getting a new valve, which delayed the procedure by less than 10 minutes.The issue occurred during bronchoscopy procedure.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide a correction to d2 from the initial medwatch.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The subject device was not returned to olympus for evaluation.However, during the investigation, a device from a different lot was tested, and it was confirmed that after pulling the suction tube connected to the suction valve and rotating the suction valve, the device detached from the endoscope.The device history record was unable to be reviewed for this device since the serial/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 investigation, it was determined that when the suction tube connected to the suction valve was pulled, and the suction valve was rotated, the suction valve unintentionally detached from the endoscope.However, the root cause could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿9.6 removing the suction valve from the endoscope: 1.Rotate the suction connector clockwise with your thumb.2.Remove and discard the suction valve.¿ this supplemental report includes a correction to d8, e1, and e3 from the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE SUCTION VALVE (STERILE)
• Common Device Name: SINGLE USE SUCTION VALVE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT; 34-3 hirai, hinode-machi; nishitama-gun, tokyo 190-0 182; JA 190-0182
• Manufacturer (Section G): OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT; 34-3 hirai, hinode-machi; nishitama-gun, tokyo
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19019426
• Report Number: 3003637092-2024-00050
• Device Sequence Number: 17789689
• Product Code: EOQ
• UDI-Device Identifier: 14953170152426
• UDI-Public: 14953170152426
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K061313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/05/2024
• 2 Devices were Involved in the Event: 1 2

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-209
• Device Lot Number: UNKNOWN
• 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: 03/13/2024
• Supplement Date Received by Manufacturer: 05/06/2024; 06/03/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 05/06/2024; 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown