MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ADAPTOR BIOPSY VALVE; SINGLE USE ADAPTER BIOPSY VALVE

Model Number	MAJ-1414
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Unspecified Eye / Vision Problem (4471)
Date of Event	07/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
The customer reported to olympus during a bronchoscopy, a student was splashed in the eye with bloody fluid from the subject device, one way valve.The needle was withdrawn, and while the respiratory therapist was flushing the sample out of the scope, the patient coughed.The subject device did not seal and blood and body fluid came out through the endoscope valve and into the student's eye.The student was sent to the emergency room for the exposure.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the customer.New information added to: b5, d10.
Event or Problem Description
The customer reported additional information: the patient is reported as doing well.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the findings are as follows: mq performed a visual inspection on the as is received condition of the device; observed that the device was returned in a clear plastic jar with an orange top.Inside the container was the valve along with two other small black pieces.The biopsy valve along with the two black pieces were removed from the container and examined under a microscope.Mq identified on end of the biopsy valve near the tab is split as it is damaged.On the inside of the biopsy valve some of the portions of the plastic are damaged as deformities and scrapes are present.The split on the tab starts from the bottom of the tab and ends at the top of the tab which was measured with a caliper at approximately 7.5 mm.Mq is unable to test this biopsy valve due to the valve being damaged as the valve will not be able to properly attach and secure on the test endoscope.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 bodily fluid leakage was likely caused by pressure being applied from the distal end of the scope due to a high pressure setting by the facility, and/or from deterioration, scratches, and deformation of the rubber part of the forceps plug resulting in air leakage from the slit.This likely resulted in fluid to leak from the forceps stopper.However, a root cause could not be determined.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This supplemental report is being submitted to clarify the event and provide corrected data.Event clarification = b5 and corrected data = g2.
Event or Problem Description
Event clarification: the reported issue involved a student in the procedure.No patient issues reported.

• Brand Name: SINGLE USE ADAPTOR BIOPSY VALVE
• Common Device Name: SINGLE USE ADAPTER BIOPSY VALVE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15175766
• Report Number: 9614641-2022-00109
• Device Sequence Number: 12053115
• Product Code: PSV
• UDI-Device Identifier: 04953170181009
• UDI-Public: 04953170181009
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K050503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MAJ-1414
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2022
• 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: 07/06/2022
• Supplement Date Received by Manufacturer: 08/04/2022; 10/12/2022; 11/07/2022; 11/08/2022
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 08/30/2022; 11/04/2022; 11/07/2022; 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BF-UC180F, UNKNOWN SERIAL; NA-U401SX-4021 , KR227354; UNKNOWN ENDOSCOPE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown