MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. HIGH FLOW INSUFFLATION UNIT

Model Number UHI-4

Device Problem Failure to Auto Stop (2938)

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

Event Date 08/29/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned to an olympus service center for evaluation.Upon inspection and testing of the returned device, the reported issue (failure of device auto shutdown function) was confirmed and found to be caused by cr board (printed circuit board) failure.When the device did not connect to the gas bottle, the gas supply was continued by pressing the gas supply button.The total gas flow continued to increase, and the lack of gas in the pipeline could not be detected and the gas supply could not be automatically stopped.The internal wiring was checked, and no looseness was found.The issue was resolved after replacing the cr board.According to the service manual, the cr board has pneumoperitoneum control function, a user interface control function, and a peripheral device communication function.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.Based on the results of the legal manufacturer's investigation, it is likely the subject device auto shut down function failed due to failure of the printed circuit board.However, a definitive root cause could not be determined.Olympus will continue to monitor field performance for this device.

Event Description

An olympus field service engineer (fse) reported the subject device failed to stop automatically.The device is an olympus loaner.There was no patient or user injury reported due to the event.Additional details have been requested regarding the reported issue.At this time, no additional information has been provided.

Manufacturer Narrative

This report is being supplemented to provide additional information that was received from the fse regarding the reported issue.Information provided in b5.

Event Description

Additional information was received from the field service engineer (fse) regarding the reported event (the subject device failed to stop automatically): the reported issue was not reported by the user.It was observed after the subject device was returned to the spare parts center for testing.

• Brand Name: HIGH FLOW INSUFFLATION UNIT
• Type of Device: HIGH FLOW INSUFFLATION UNIT
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15501425
• MDR Text Key: 306320877
• Report Number: 3002808148-2022-02542
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/18/2022

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
• Device Operator: Health Professional
• Device Model Number: UHI-4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/29/2022
• Initial Date FDA Received: 09/29/2022
• Supplement Dates Manufacturer Received: 09/28/2022
• Supplement Dates FDA Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2021
• 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