MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT SINGLE USE SUCTION VALVE (STERILE); ENDOSCOPIC PROCEDURE AIR/WATER VALVE, SINGLE-USE

Model Number	MAJ-209
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	01/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was evaluated by olympus.The evaluation found that the allegation was not confirmed.The subject device evaluation reported on one box of single-use suction devices.It was noted that the box quantity is for (b)(4) pieces, but only (b)(4) pieces were returned.All the valves were brand new and in sealed, sterile packaging.Market quality examined (b)(4) of (b)(4) pieces and discovered no defects in the appearance, as each button, spring, main body, and suction connector was intact and functional.Each valve was checked with the test bronchovideoscope bf-1t180, with the arm of the main body aligning with the white mark on the endoscope.The suction valve¿s top white surface was pressed down with both thumbs until it clicked into place.The base of the valve was in proper contact with and fully seated in the test suction cylinder.The valves were checked for suction function and passed the functional inspection.It was noted that water was continuously aspirated into the suction bottle of the suction pump and valves did not pop out from the suction cylinder during the activation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported to olympus that the single-use suction valve pops out of the port too easily during a procedure.The customer tested the subject device with both the 180 and 190 series scopes, and the same issue was reported.The intended procedure was completed using a similar device, with no reports of patient harm were associated with this event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to g2.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¿s likely the connection was not sufficient, and the valve became loose and detached.However, a final root cause of this event was unable to be identified, as the event was unable to be duplicated during the device evaluation.The following is included in the instructions for use: ¿7.3 attaching the biopsy valve to the endoscope.Make sure that maj-209 is properly connected to the endoscope with no space.¿ olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being submitted to correct the fda product code to eoq.

• Brand Name: SINGLE USE SUCTION VALVE (STERILE)
• Common Device Name: ENDOSCOPIC PROCEDURE AIR/WATER VALVE, SINGLE-USE
• 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: 16274532
• Report Number: 3003637092-2023-00018
• Device Sequence Number: 5949797
• Product Code: EOQ
• UDI-Device Identifier: 14953170152426
• UDI-Public: 14953170152426
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2024
• 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: H1704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2023
• 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: 01/06/2023
• Supplement Date Received by Manufacturer: 04/19/2023; 05/06/2024
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 05/16/2023; 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2021
• 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