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	08/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The investigation is ongoing.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
A user facility reported to olympus the possible use of non-sterile balloon2 on a patient.There were no reports of patient harm for the unidentified diagnostic procedure.
Additional Manufacturer Narrative
"this report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Updated fields: h6 and h10.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 instructions for handling before use on the label of unsterilized balloons (mh-303, maj-213) state "sterilize if necessary," but the instructions for handling before use in the package insert state "must be sterile.'' it was used unsterilized at the facility.The suggested event is detectable and preventable by handling the scope in accordance with the following section of the instructions for use: 1.Sterilization.Be sure to sterilize with ethylene oxide gas before use.For sterilization methods, refer to the "instruction manual'' of the ethylene oxide gas sterilizer.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: 17653342
• Report Number: 3002808148-2023-09204
• Device Sequence Number: 7212548
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2023

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: 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: 08/03/2023
• Supplement Date Received by Manufacturer: 09/03/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 09/14/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown