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

Model Number UHI-4

Device Problem Increase in Pressure (1491)

Patient Problem Cardiac Arrest (1762)

Event Date 09/26/2023

Event Type  Death  

Manufacturer Narrative

The device was not returned 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.

Event Description

The customer reported that when using a high flow insufflation unit, the output pressure was excessive and there was no alarm to notify the user.The pressure set was 12mmhg.The flow rate was set to high.The indication of insufflation pressure was stable.There was no other gas source.The pressure was normal, there was no overpressure alarm.There was no pipe blockage alarm and no suction tube connected.There was no abnormal abdominal swelling.The event occurred during the therapeutic procedure (laparoscopic excision of bladder mass).The patient expired after emergency resuscitation measures.The hospital stopped using the three existing uhi-4 machines in the department after the event.Additional information regarding the event has been requested but not provided at this time.

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.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, a relationship between the patient death and the device was not confirmed.Therefore, the root cause of the adverse event or device failure could not be determined.This supplemental report includes a correction to b1 and g2 to provide information that was inadvertently not included in the initial medwatch.Also, information has been added to b5 and b7 from the initial medwatch.Olympus will continue to monitor field performance for this device.

Event Description

It was reported that the customer suspects that the olympus device contributed to the patient¿s death.Per the facility, the patient suffered a cardiac arrest during the procedure.An autopsy was not performed.

• 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: 18317471
• MDR Text Key: 330364769
• Report Number: 3002808148-2023-14186
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• 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,Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Initial Date Manufacturer Received: 11/15/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 04/16/2024
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0075-2024
• Patient Sequence Number: 1
• Treatment: OTS-S400.; OTV-S190 VISERA ELITE VIDEO SYSTEM CENTER.
• Patient Outcome(s): Death
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 60 KG