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

Model Number	MAJ-213
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Attempts to retrieve additional information from the customer are in progress.This event is under investigation.A supplemental report will be submitted upon receiving additional information.
Event or Problem Description
The customer reported that a non-sterile balloon may have been used on the patient.There was no reported patient harm or impact due to this event.
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.The manufacturing date was unable to be determined.Based on the results of the investigation, the sterilization issue may have been caused by the user misunderstanding the labeling.However, because the device was not returned for evaluation, the definitive root cause of the event could not be determined.Pre-use handling methods listed on the labels of unsterilized balloons are described as "sterile as needed," whereas the pre-use handling of the package inserts are described as "sterile".At the facility, it was left unsterilized.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿please be sure to sterilize ethylene oxide gas before use.For sterilization methods, please refer to the "instructions for use" for the ethylene oxide gas sterilizer.Regarding the conditions for ethylene oxide gas sterilization, see table 1 and table 2.¿ olympus will continue to monitor field performance for this device.

• Brand Name: BALLOON
• 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: 17640250
• Report Number: 3002808148-2023-09076
• Device Sequence Number: 20729241
• Product Code: FDS
• UDI-Device Identifier: 04953170355714
• UDI-Public: 04953170355714
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K963023
• 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): 09/12/2023

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: MAJ-213
• 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: 08/02/2023
• Supplement Date Received by Manufacturer: 09/03/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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