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

Model Number	MH-303
Medical Device Problem Code	Problem with Sterilization (1596)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the balloon2 may have been used non-sterile in a procedure.There were no reports of patient harm.This report is related to linked patient identifier (b)(6).
Additional Manufacturer Narrative
E1: establishment name: (b)(6).Based on the results of the investigation, it is likely that the following led to the malfunction: the root cause of the failure event was not identified.Based on the facts obtained in the survey, it is presumed that the labeling was incorrect and the user was not aware that sterilization was necessary.This issue is addressed in the instructions for use (ifu): the pre-use handling instructions on the label of unsterilized balloons (mh-303, maj-213) state "sterilization as necessary", but the pre-use handling instructions on the package insert state "sterile as necessary".It was used unsterilized at the facility.Olympus will continue to monitor the field performance of this device.The instruction manual states: 1.Sterilization always sterilize ethylene oxide gas before use.For the sterilization method, refer to the "instruction manual" of the ethylene oxide gas sterilizer.The conditions for ethylene oxide gas sterilization are table l, table 2.Olympus will continue to monitor the field performance of this device.
Additional 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, it can be presumed that the event was caused because the user was not aware 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: 17789353
• Report Number: 3002808148-2023-10143
• Device Sequence Number: 12630686
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2024

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
• Was Device Available for Evaluation?: No
• 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: 08/24/2023
• Supplement Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 05/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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