MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT 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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was not sent to olympus for evaluation.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
The customer reported that, during a procedure, the subject device could not be fixed properly in the cylinder.When the valve was turned and the suction hose was under its own weight, it fell out.This occurred with multiple endoscope models and is a general complaint about the general form of the valves.The user was able to use the device by holding the valve with the suction hose.There was no procedural impact or patient harm associated with the event.
Event or Problem Description
The reported event occurred during normal bronchoscopy or endobronchial ultrasound (ebus) procedure with puncture.The procedure was completed, but the valve needed to be replaced.The customer reported there was no clinically relevant prolongation of the procedure due to the defect.However, it disturbs the course of the procedure if you have to keep holding the valve with the suction hose.There was no harm to the patient.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to b5.The information included in b5 was inadvertently omitted from the initial medwatch report.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, the following are probable causes of the loose connection: due to variability in molding process, the valve was made within standard, but its loosening torque was close to the tolerance limit.The valve deformed and became loose due to repetitive use.The final root cause of this event was unable to be identified.The following is included in the instructions for use: ¿if the valve cannot be securely attached, please replace it with a new one.Use of this device is not recommended for more than six(6) procedures.If any of the following irregularities are observed during use, replace with a new valve immediately.The valve is not secure after attachment.The solution fed with a syringe is aspirated into the suction container without operating the valve.The valve comes off easily during use.Air is aspirated from the distal end of the endoscope without operating the valve.¿.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. 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: 16230842
• Report Number: 3003637092-2023-00014
• Device Sequence Number: 12380807
• Product Code: FAJ
• UDI-Device Identifier: 04953170063428
• UDI-Public: 04953170063428
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2023

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: H9Z16
• 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: 11/07/2022
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2019
• 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
• Patient Sex: Unknown