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

Model Number	MH-303
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.The device history review was not performed due to the lot (or serial number) is unknown.Based on the results of the investigation, the definitive root cause of the issue could not be determined.It is described to [sterilize if necessary] in the handling procedure before-use in the labelling of unsterilized balloon.In the handling procedure before use in the attached document, it is described that [always sterilize.The facility may have used the device without sterilizing.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: always conduct ethylene oxide gas sterilization before use.Refer to [instruction manual] of ethylene oxide gas sterilization device for sterilization procedure.For conditions of ethylene oxide gas sterilization, refer to table 1 and table 2.Olympus will continue to monitor field performance for this device.
Event or Problem Description
Cic safety notified olympus by mail that during a diagnostic ultrasound endoscope procedure, an unsterilized balloon 2 was used on a patient.There were no reports of patient harm.Related to patient identifier: (b)(6).
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.In the handling methods prior to use written in the label of a non-sterilized balloon (mh-303, maj-213), it was stated as ¿sterilize as necessary.¿ however, in the handling methods prior to use written in the package insert, it was stated as ¿always sterilize.¿ the facility used it without sterilizing.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: 17777555
• Report Number: 3002808148-2023-10067
• Device Sequence Number: 15015960
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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
• Device Lot Number: UNKNOWN
• 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: 08/21/2023
• Supplement Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 05/30/2024
• 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