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

Model Number	OBCU
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384); Output above Specifications (1432)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was received and evaluated.The reported issue of abnormal noise was reproduced.Device evaluation found the rubber foot of the pump was broken resulting in abnormal noise.The failure found was found to be due to faulty relief valve causing the safety air pressure exceeded the limit.Repair history review of this product noted the concerned product has not been repaired in the past year.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
The customer reported an abnormal sound (loaner from olympus).No harm was reported.No patient harm, no user injury reported as the result of the reported issue.
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.It has been over 13 years since the subject device was manufactured.Based on the results of the investigation, it is likely the safety air pressure exceeded the limit due to a faulty valve unit.However, a definitive root cause 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: 16070322
• Report Number: 3002808148-2022-05736
• Device Sequence Number: 6705079
• Product Code: FDA
• UDI-Device Identifier: 04953170239533
• UDI-Public: 04953170239533
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2023

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: 12/06/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2022
• Supplement Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2009
• 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
• Patient Sex: Unknown