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

Model Number UHI-4

Device Problem Disconnection (1171)

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

Event Date 06/19/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that while using the high flow insufflation unit, the power cord on the insulated transformer side of the trolley was disconnected, and all power of the combined equipment was lost.The issue occurred during a therapeutic procedure (right partial lung resection and mediastinal lymph node biopsy).The procedure was able to be completed with the same device.There were no reports of patient harm.This report is related to the following linked patient identifiers: (b)(6) and (b)(6).

Manufacturer Narrative

The customer was reportedly able to correct the issue was resolved; power was automatically restored when the cord was re-inserted.As such, the device is not expected to be returned to olympus for evaluation.The investigation is ongoing, and 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 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 power connector on the insulated transformer side of the trolley was easily loosened.The cause of loosening is likely to be vibration when moving the trolley or to be worn out due to long-term use.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information provided by the customer: d10.

• 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: 17347274
• MDR Text Key: 319423125
• Report Number: 3002808148-2023-07250
• 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,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2023

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/19/2023
• Initial Date FDA Received: 07/18/2023
• Supplement Dates Manufacturer Received: 06/19/2023; 08/09/2023
• Supplement Dates FDA Received: 07/18/2023; 08/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2018
• 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
• Treatment: CLV-S200-IR SERIAL NO.(B)(6).; LMD-X310ST SERIAL NO.(B)(6).; OTV-S300 SERIAL NO.(B)(6).; WM-NP2 WORKSTATION SET 5 SERIAL NO.(B)(6).