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

Model Number UHI-3

Device Problem Unexpected Shutdown (4019)

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

Event Date 11/09/2023

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 the insufflator power went off during a therapeutic gynecological procedure.The power to all the onboard equipment went out.Immediately after that, power was restored without any intervention.The procedure was completed using the same set of equipment.There were no reports of patient harm or impact associated with this event.The facility staff suspected that there was a problem with the isolation transformer, and as repairs were planned, they will not be returning any of the equipment.This report is related to the following linked patient identifiers: (b)(6), to capture the additional products involved that also powered down.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The dhr was unable to be reviewed for this device since it was manufactured over 15 years ago.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The case is not due to design.Based on the results of the legal manufacturer's investigation, and the inability to evaluate the subject device, a definitive root cause of the device powering down could not be identified.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: 18215070
• MDR Text Key: 329081377
• Report Number: 3002808148-2023-13334
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170140297
• UDI-Public: 04953170140297
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K014166
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/15/2024

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-3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 12/25/2023
• Supplement Dates FDA Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2008
• 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-S190 VISERA ELITE XENON LIGHT SOURCE.; IMH-10 IMAGE MANAGEMENT HUB.; K10021610 WM-NP2 WORKSTATION.; OEV262H HIGH DEFINITION LCD MONITOR.; OTV-S190 VISERA ELITE VIDEO SYSTEM CENTER.