MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. BALLOON2

Model Number	MH-303
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus, that an unsterilized balloon 2 was used in a patient.The intended procedure was completed using the same device.There were no reports of harm to patients.The distributor checked with customer information center to see if balloon 2 could be sterilized with stellad.It was discovered that the facility was unable to handle gas sterilization, and that an unsterilized ultrasonic balloon was misused.The balloon had not been used since the discovery.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, updated b3 and correction to h8.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 specific root cause of the event could not be determined at this time.However, olympus sent an endoscopic support specialist (ess) to the site for reprocessing training.The suggested event may be prevented by handling the device in accordance with the instructions for use (ifu): "[handling methods] 1.Sterilization make sure to perform ethylene oxide gas sterilization prior to use.As to the sterilization methods, refer to the instruction manual of an ethylene oxide gas sterilization device.For the conditions of ethylene oxide gas sterilization, refer to table l and 2." olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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, root cause could not be identified although it can be presumed that it was due to the user unaware that sterilization was necessary because the label was wrong.The events can be detected/prevented in accordance with the following instructions for use: [handling methods] 1.Sterilization make sure to perform ethylene oxide gas sterilization prior to use.As to the sterilization methods, refer to the instruction manual of an ethylene oxide gas sterilization device.For the conditions of ethylene oxide gas sterilization, refer to table l and 2.Olympus will continue to monitor field performance for this device.

• Brand Name: BALLOON2
• Common Device Name: BALLOON
• 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: 18273606
• Report Number: 3002808148-2023-13794
• Device Sequence Number: 5760585
• Product Code: FDF
• UDI-Device Identifier: 04953170355721
• UDI-Public: 04953170355721
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K926514
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2024

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: MH-303
• Device Lot Number: UNKNOWN
• 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: 11/14/2023
• Supplement Date Received by Manufacturer: 01/05/2024; 05/27/2024
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 01/08/2024; 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown