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

Model Number	OBCU
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and inspected.The allegation was not confirmed.The device did not show any errors in function during the inspection.The balloon was reliably inflated or deflated.Corrosion was observed on top cover, chassis, connector and front panel.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 customer reported to olympus that at the end of an enterosocopy for anemia, using this balloon control unit, inflation problem, abnormal pressure was observed.It provided a negative 2 and a deflated balloon but when the hose was removed, the balloon was still inflated resulting in minimal mucosal erosion.There was no delay in the procedure.No clinical and therapeutic findings, the patient was discharged the next day.The device was checked before use.Additional information has been requested, but no information has been received at this time.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information, based on the approved final investigation.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 and since the device malfunction (the balloon remains inflated when the hose is removed) was not confirmed, during evaluation.The definitive root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for this device.

• 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: 18048654
• Report Number: 3002808148-2023-12108
• Device Sequence Number: 20700058
• Product Code: FDA
• UDI-Device Identifier: 04953170239533
• UDI-Public: 04953170239533
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2024

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: OBCU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2023
• Supplement Date Received by Manufacturer: 12/28/2023
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2008
• 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: SIFQ-180 SERIAL (B)(6).; ST-SB1.
• Patient Sex: Unknown