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

Model Number	MAJ-209
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The client was informed by the company representative that that practice was not in accordance with the product and it was requested that the client disposes the device after use and that a new one be placed with the endoscope before the examination.The device was not returned.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was observed that during the device estimation, the single-use pistons of the bronchoscopes, the client reused the single-use pistons on the bronchoscopes by disassembling them and passing them through the pereacetic acid (paa) washers.There were no reports of patient involvement.
Additional Manufacturer Narrative
This supplemental report is to inform that upon further review, this is not a reportable malfunction.The initial medwatch reported the client reused the single-use pistons on the bronchoscopes by disassembling them and passing them through the peracetic acid (paa) washers.However, per the legal manufacturer, this issue is not likely to cause or contribute to death or serious injury if the malfunction were to recur.
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: 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: 18589683
• Report Number: 3003637092-2024-00017
• Device Sequence Number: 6519783
• Product Code: EOQ
• UDI-Device Identifier: 14953170152426
• UDI-Public: 14953170152426
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/07/2024
• 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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2023
• Supplement Date Received by Manufacturer: 02/27/2024; 05/07/2024
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 03/12/2024; 05/07/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown