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

Model Number UHI-4

Device Problems Break (1069); Corroded (1131); No Device Output (1435)

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

Event Date 09/04/2023

Event Type  malfunction  

Event Description

The olympus representative (on behalf of the customer) reported to olympus, when the high flow insufflation unit is activated, only the power switch is active (everything else is not active).The issue was found during preparation for use.There was no procedural involvement and there were no reports of patient harm.

Manufacturer Narrative

The device¿s return is anticipated; however, the device has not yet been returned to olympus for evaluation.The investigation is ongoing, a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This report is being supplemented to provide additional information provided by the device evaluation.The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found that the front panel was damaged, corrosion was found inside of the device / on the real panel / top cover / chassis / printed circuit board / electro pneumatic valve / manifold unit / and regulator unit, which caused the device to be non-functional.

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.Based on the results of the investigation, it is likely that the corrosion inside the device remained and the device does not work occurred due to moisture damage to the inside of the device (likely caused by wrong user handling/user mishandling).The event can be prevented by following the instructions for use (ifu) which state: "[important information ¿ please read before use] keep fluids away from all electrical equipment.If fluids are spilled on or into the high flow insufflation unit, stop operation of the unit immediately and contact olympus.[6.7 storage of the high flow insufflation unit, foot switch, cylinder hose, and medical gas pipeline adapter] store the equipment in a place not exposed to direct sunlight by avoiding exposure to high temperature, high humidity, or water splashes." 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 (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: 17824847
• MDR Text Key: 324355774
• Report Number: 3002808148-2023-10440
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• 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,Followup
• Report Date: 11/28/2023

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
• Device Operator: Health Professional
• Device Model Number: UHI-4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/05/2023
• Initial Date FDA Received: 09/27/2023
• Supplement Dates Manufacturer Received: 09/29/2023; 11/20/2023
• Supplement Dates FDA Received: 10/05/2023; 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2019
• 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