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

Model Number	MH-303
Medical Device Problem Code	Problem with Sterilization (1596)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No devices were returned for evaluation.The customer reported that a non-sterilized balloon was used with patient; this issue could be confirmed.This issue is listed as a hazard in the device risk analysis.The device history record could not be reviewed; no lot number information was provided.The device instructions for use document was reviewed.Review showed relevant instruction under the sterilization section: "make sure to perform ethylene oxide gas sterilization prior to use.As to the sterilization methods, refer to the instruction manual of an ethylene oxide gas sterilization device.For the conditions of ethylene oxide gas sterilization, refer to table 1 and 2." review of the device label showed the handling methods section stated "sterilize as necessary".The package insert labeling, however, stated "always sterilize".The difference between the labels was identified as a potential cause of the issue.However, the root cause of the reported issue was not definitely confirmed.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer reported to olympus that the balloon was used during a diagnostic ultrasound endoscopy procedure.The customer had not performed gas sterilization of the balloon prior to use.The procedure was completed with the same device.There were no reports of patient harm or health damage.This report is related to linked patient identifiers (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.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: 18301853
• Report Number: 3002808148-2023-14048
• Device Sequence Number: 15187643
• 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): 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
• 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: 11/22/2023
• Supplement Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 12/11/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GF-UE290: ULTRASOUND GASTROINTESTINAL VIDEOSCOPE
• Patient Sex: Unknown