MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT SUCTION VALVE; ENDOSCOPIC SUCTION VALVE, REUSABLE

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)
Date of Event	02/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has been returned to olympus for evaluation and the reported issue was confirmed.The investigation is ongoing, and a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
The customer reported to olympus, during a receipt inspection, the suction valve could not be correctly attached to an endoscope and easily detaches, which caused the valve to move out of position when moving the endoscope.There was no patient involvement in this event.
Additional Manufacturer Narrative
A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, it¿s likely that improper fitting of the valve into the scope resulted in drop-off of the valve.The final root cause of this event was unable to be identified.The following is included in the instructions for use: ¿6.1 attachment of suction valve (fig.1 and fig.2) firmly attach the suction valve to the suction cylinder of the endoscope.If the suction valve is attached to the endoscope improperly with a gap between the base of the suction valve and the top of the suction cylinder, the suction valve may detach from the endoscope and/or may cause patient debris to leak or spray from the gap, posing an infection-control risk.1.Place the suction valve into the suction cylinder aligning the arm of the main body with the white index mark on the endoscope.Push down on the suction valve button with your finger until it clicks into place.2.Inspect and verify that the base of the valve is in contact with the suction cylinder properly.Improper attachment, where a gap still exists between the base of the suction valve and the top of the suction cylinder¿ olympus will continue to monitor field performance for this device.

• Brand Name: SUCTION VALVE
• Common Device Name: ENDOSCOPIC SUCTION VALVE, REUSABLE
• 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: 16593134
• Report Number: 3003637092-2023-00071
• Device Sequence Number: 19556502
• Product Code: KNS
• UDI-Device Identifier: 04953170063428
• UDI-Public: 04953170063428
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2023

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: H0924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2020
• 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