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

Model Number OBCU

Device Problems Break (1069); Mechanical Problem (1384); Output above Specifications (1432)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2022

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 308465750
• Report Number: 3002808148-2022-05736
• Device Sequence Number: 1
• Product Code: FDA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K071254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1