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

Model Number UHI-4

Device Problem No Display/Image (1183)

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

Event Date 11/28/2022

Event Type  malfunction  

Event Description

The customer reported to olympus that the front panel display on the high flow insufflation unit was not functioning; even though there was output.The event was discovered during maintenance.There was no report of patient harm or user injury associated with this event.

Manufacturer Narrative

The subject device was returned and evaluated.The reported problem was confirmed.The front panel display disappeared after switching on the equipment.This was likely caused by a faulty circuit board.The evaluation also uncovered the following: the flat cable was rusty, the power switch was noisy, the there was a gas leak from the connector, corrosion was found on the top cover rear panel, chassis and the screw of the pinch valve, and the front panel had scratches.The investigation is ongoing.A supplemental report will be submitted upon completion.

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 4 years since the subject device was manufactured.Based on the results of the investigation, it¿s likely the front panel did not function due to a printed circuit board failure.However, a final root cause of this event was unable to be identified.Additionally, the root cause of the gas leak from the connector unit was unable to be identified.Olympus will continue to monitor field performance for this device.

Event Description

During the device evaluation, it was confirmed that there was gal leaking from the connector.This report is being submitted for the gas leak from the connector unit and the front panel non-functioning.

• 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 (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: 16062375
• MDR Text Key: 308526904
• Report Number: 3002808148-2022-05676
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K122180
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• 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: 11/29/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2019
• 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