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

Model Number UHI-4

Device Problem Failure to Clean Adequately (4048)

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

Event Date 07/25/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation, and the customer's allegation was confirmed.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

An olympus representative reported to olympus on behalf of the customer that the high flow insufflation unit had body fluid flowed back and entered the device after the therapeutic procedure.The intended procedure was completed with the same equipment.There were no reports of patient harm or impact associated with the reported event.

Manufacturer Narrative

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 event occurred due to the following (user handling): uhi-4 was installed lower than the patient.Uhi-4 was connected to an insufflation tube, and the tube was installed higher than the co2 feed port while blood or body fluids were inside the tube.The relief mode was turned on without using a filter.The event can be prevented by following the instructions for use (ifu) which state: "[chapter 5 operation] install this instrument at a higher altitude than the patient.Otherwise, the blood and body fluid of the patient may contaminate the high-flow insufflation unit through the insufflation tube.[5.12 steps after use] if blood and body fluid penetrate inside the insufflation tube that is connected to the high-flow insufflation unit, be careful not to bring the insufflation tube at a higher level than the co2 feed port of the insufflation unit when disconnecting the tube.Otherwise, the blood and body fluid may enter the insufflation unit and contaminate it.[5.13 relief mode] when relief mode is set to on, the intra-cavity gas will flow backward into the equipment for relief through the built-in valve.To prevent the internal surfaces of the equipment from being contaminated, be sure to use a disposable filter.When no filter is used, make sure relief mode is set to off." 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: 17592871
• MDR Text Key: 321683035
• Report Number: 3002808148-2023-08705
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/27/2023

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
• Date Returned to Manufacturer: 07/27/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/27/2023
• Initial Date FDA Received: 08/21/2023
• Supplement Dates Manufacturer Received: 10/27/2023
• Supplement Dates FDA Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2022
• 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