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

Model Number	OBCU
Medical Device Problem Codes	No Audible Alarm (1019); Inflation Problem (1310)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	08/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and evaluated, and during testing of the device, the customer's allegations could not be confirmed.The operation of the pump and visual examination showed no abnormalities found, and the alarm sounded when air was supplied for more than 20 seconds.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Event or Problem Description
The olympus representative reported on behalf of the customer that during the therapeutic endoscopy in the small intestine, the balloon control unit continued to inflate in the intestine without stopping the air supply and the alarm did not sound.The power was turned off to release the air supply, the device was then removed, and the procedure was completed.The procedure time was slightly extended and congestion to the patient's mucous membrane was seen.The event did not affect the outcome of the procedure.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to the initial with information inadvertently left out.Additionally, to provide additional information received through follow up ((b)(4)).A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is possible that the phenomenon "the balloon could not stop supplying air and continued to inflate inside the intestine." and the phenomenon "due to this defect, the procedure time was prolonged and congestion of the patient's mucous membranes was observed." occurred due to deterioration of the control board since 13 years have passed since delivery and there is no repair history, but the phenomenon is not reproducible.Therefore, the root cause of the phenomenon's could not be determined.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No cleaning, disinfection, and sterilization conditions because it is a box item.The procedure was completed with the same device and the frequency of use or number of times of use is unknown.The purpose of the procedure was inspection.Information not available on what congestion to the mucous membrane is.No additional intervention or additional treatment.No health damage to the patient due to the event.Additionally, information received unsure if "balloon air cannot be stopped" but it does not stop even if you press the pump pause switch or if "the alarm does not sound" this only occurs if inflated for 20 seconds or more.Unable to obtain the exact time for the power to be turned off.When the user connected the balloon, it swelled, and there were no scratches and there seemed to be no air leakage.The user doesn¿t remember if there were warning indicator lamps on the main unit and/or obcu remote controller tipped over when the phenomenon occurred.

• Brand Name: BALLOON CONTROL UNIT
• Common Device Name: BALLOON CONTROL UNIT
• 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: 17789900
• Report Number: 3002808148-2023-10152
• Device Sequence Number: 6454772
• Product Code: FDA
• UDI-Device Identifier: 04953170239533
• UDI-Public: 04953170239533
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K071254
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2023

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: OBCU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2010
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ST-SB1SSINGLE-USE SPLINTING TUBE
• Patient Sex: Unknown