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

Model Number UHI-4

Device Problem Insufficient Information (3190)

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

Event Date 11/21/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not 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.

Event Description

The customer reported to olympus, that there was an error when starting up with the high insufflation unit during the therapeutic laparoscope procedure.The issue was found during preparation for use.The procedure was completed with another device.There were no reports of patient harm.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Correction to d4, h4 of the initial medwatch.The device was returned to olympus for inspection, the device evaluation found the equipment sounded an alarm and the front panel display would disappear (shutdown with front panel light turned off).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, the likely cause of the reported event is due to pressure sensor (cr board) circuit board failure.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: 18293015
• MDR Text Key: 330826220
• Report Number: 3002808148-2023-13982
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2018
• 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: OTV-S400- VISERA 4K UHD CAMERA CONTRAL UNIT