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

Model Number MAJ-1444

Device Problems Use of Device Problem (1670); Device Contamination with Body Fluid (2317); Failure to Clean Adequately (4048)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/09/2023

Event Type  malfunction  

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 jan 10, 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.Further due diligence for the events is being performed.

Event Description

As reported by the customer for this event, a 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 of the scope.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.The scope had been used in a procedure three days previously, and the bed-side cleaning was not immediately performed for the device.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.This device also had presence of blood.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.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial 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, the definitive root cause of the reprocessing error could not be determined.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

Additional information has been received for this event from the customer.This supplemental report is being submitted to provide this information.The concomitant device used in the procedure is eu-me2 (serial no.(b)(6)).No other information available for the procedure and the patient of the procedure.

Event Description

Addendum feb 8, 2023: pre-use inspection of the scope was not carried out prior to the procedure.The procedure was completed by replacing the device.There was a delay of approximately five minutes due to device replacement.

• Brand Name: AIR/WATER VALVE
• Type of Device: 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: 16291897
• MDR Text Key: 308727710
• Report Number: 3002808148-2023-01035
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170355929
• UDI-Public: 04953170355929
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K051645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-1444
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: OER-4.