MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. AIR/WATER VALVE

Model Number	MAJ-1444
Medical Device Problem Code	Use of Device Problem (1670)
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
There are two events for the devices gf-uct260 (ultrasound gastrovideoscope) and maj-1444 (ultrasonic endoscope air/water valve).First event on (b)(6) 2023, when the scope was not reprocessed as per the instructions for use.Second event on (b)(6) 2023, when the said scope was used in a procedure and failed; in the subsequent reprocessing, the scope had presence of blood.These events are captured in medwatches with patient identifiers as follows: first event of (b)(6) 2023: (b)(6) (gf-uct260) (b)(6) (maj-1444).Second event of (b)(6) 2023: (b)(6) (gf-uct260) and (b)(6) (maj-1444).This medwatch is for the patient identifier (b)(6).Post the issue of (b)(6) 2023, an olympus endoscopy support specialist (ess) visited the facility.The correct reprocessing method was explained to the facility.Subsequently, the device has been fully reprocessed again with primary cleaning and high level disinfection i the oer-4 automatic preprocessor.It has been confirmed that there is no presence now in the device.Customer has no other issue of malfunction of the device.As such, the customer is not sending in the device for repair, and the device is not available for evaluation.As such, a definitive root cause of the reported complaint cannot be determined at this time.This event is under investigation.A supplemental report will be submitted upon completion of the investigation or upon receiving additional information.
Event or Problem Description
As reported by the customer for this event, after using the scope in a diagnostic endoscopic ultrasound (eus) procedure, the bed-side cleaning was not immediately performed for the scope.The scope was not soaked in detergent solution, and the air/water nozzle was not flushed with water and air.For the manual cleaning, the air/water nozzle was not wiped/brushed with lint-free gauze, brush, or sponge.The air/water nozzle was flushed with detergent solution.No information provided on accessories used for reprocessing.Subsequently, three days later the scope was used in a diagnostic endoscopic ultrasound (eus) and found to have failed with air and water supply.Post the procedure, during reprocessing, it was observed that a large amount of blood came out of the air channel.There is a possibility that this blood may have been in the scope from the reprocessing not performed correctly three days previously.There is no harm reported to the patient of the procedure.Further due diligence for the event, including current status of the patient, is being performed.There are two devices involved in this event (and two events three days apart): ultrasound gastrovideoscope and ultrasonic endoscope air/water valve.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, as well as corrections to g2 and h3.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it¿s likely the device was not reprocessed in accordance with the instructions for use due to user handling.The root cause of this event was unable to be identified.Additionally, the root cause of the foreign material was unable to be identified.However, it¿s likely the foreign material was in the device due to incorrect reprocessing.The event can be prevented by following the instructions for use which state: ¿warnings and cautions after using this valve, reprocess and store it according to the instructions given in chapter 5, ¿reprocessing: general policy¿, through chapter 11, ¿storage¿.Using improperly or incompletely reprocessed or stored instruments may cause patient cross-contamination and/or infection.¿ olympus will continue to monitor field performance for this device.

• Brand Name: AIR/WATER VALVE
• Common Device Name: AIR/WATER VALVE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16291607
• Report Number: 3002808148-2023-01033
• Device Sequence Number: 5019762
• Product Code: ODG
• UDI-Device Identifier: 04953170355929
• UDI-Public: 04953170355929
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051645
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2023

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-1444
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2023
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OER-4
• Patient Sex: Unknown