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
E1 facility name: (b)(6) hospital.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 during a therapeutic procedure.The procedure was completed with the device.There was no reported patient harm or impact due to this event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information from the customer.See b5 this event is under investigation.A supplemental report will be submitted upon receiving additional information.
Event or Problem Description
Additional information received from the customer reported that it was unknown if the procedure was delayed or how the procedure was completed.
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.The handling method on the non-sterile balloon¿s label stated ¿sterilize as needed¿, but the handing method on the package leaflet states ¿sterilize certainly¿.At the facility, it was left unsterilized.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿be sure to sterilize with ethylene oxide gas before use.About the sterilization method, refer to the instruction manual of the ethylene oxide gas sterilizer.Refer to the table 1 and table 2 for ethylene oxide gas sterilization conditions.¿ 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: 17640398
• Report Number: 3002808148-2023-09079
• Device Sequence Number: 14872791
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2023

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
• Device Lot Number: N/A
• 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: 08/30/2023; 09/05/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 08/31/2023; 09/15/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown