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

Model Number	MAJ-213
Medical Device Problem Code	Problem with Sterilization (1596)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number has not been provided.The subject device has not been returned to olympus for evaluation.The investigation is ongoing.And a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
It was reported, the customer did not read the sterilization instructions.And the balloon may not have been sterilized as the customer claimed.No instruction was received to sterilize the device.There was no harm or user injury reported due to the event.Patient identifier (b)(6) captures a related event.
Additional Manufacturer Narrative
The device history record was unable to be reviewed for this device since the lot 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 root cause of the balloon being used without proper sterilization could not be identified.Additionally, the root cause of the customer not receiving instruction on how to sterilize the device could not be identified.The event can be prevented by following the instructions for use which state: ¿sterilize the sterilizer with ethylene oxide gas before use.Refer to the instruction manual of the ethylene oxide gas sterilizer for the sterilization method.¿ 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: 16823142
• Report Number: 3002808148-2023-04274
• Device Sequence Number: 6820781
• 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,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2023

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 Catalogue Number: N5361430
• 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: 04/11/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 06/27/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown