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

Model Number UHI-4

Device Problems Electrical /Electronic Property Problem (1198); Noise, Audible (3273)

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

Event Type  malfunction  

Event Description

The customer reported the high flow insufflation unit front panel light is turned off and alarm ensued.The event occurred during preparation for use, prior to a diagnostic procedure.A similar device was used to complete the operation and there was no patient harm or user injury reported due to the event.

Manufacturer Narrative

The device was returned for investigation.Upon evaluation of the device, the reported issue was confirmed due to a cr board malfunction.In addition, flow rate failure display, light-emitting diode failure to work, oil leakage from depressurize, and sound of gas leakage from the regulator unit were observed.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.It has been over 6 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation: (1) the phenomenon ¿light on the front panel is turned off, and an alarm was generated¿ was duplicated, and this was determined to have occurred due to the faulty printed circuit (cr) board; (2) it was confirmed that ¿flow rate sign was not displayed, and led light did not work¿, but its cause could not be identified; (3) it was confirmed that ¿oil was leaking from the depressurizer due to a faulty depressurizer¿, but its cause could not be identified; (4) it was confirmed that the ¿sound of gas leak was coming from the regulator unit¿, and this was determined to be due to a faulty safety valve of the first regulator unit.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Olympus will continue to monitor field performance for this device.

• 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: 15138476
• MDR Text Key: 304877698
• Report Number: 3002808148-2022-00513
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/07/2022

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: 07/10/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/05/2022
• Initial Date FDA Received: 08/01/2022
• Supplement Dates Manufacturer Received: 08/19/2022
• Supplement Dates FDA Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2016
• 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