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

Model Number UHI-4

Device Problem Ambient Noise Problem (2877)

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

Event Date 11/08/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, the user¿s report was confirmed.While testing the device, the abnormal noise was present about half-way through running the unit.If additional information becomes available following the device evaluation, a supplemental report will be filed.

Event Description

The customer reported that his olympus high flow insufflation unit was producing an abnormal sound during a laparoscopic gastrectomy procedure.According to the initial reporter, the sound continued for a while, but eventually subsided, and the procedure was completed with the subject device.There was no harm to the patient as a result of this event.

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, there were a lack of characters on the light-emitting diode (led) display.However, the definitive root cause of the led display issue could not be determined.Additionally, the abnormal noise was not confirmed.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: 15914866
• MDR Text Key: 308069932
• Report Number: 3002808148-2022-04849
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• 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: 11/14/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2016
• 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