Risk of patient harm from medical device Insufflation Unit

Priority 1 - Urgent action required

Issued on: 24/11/2023

Who needs to take action?

Following the publication of an urgent Field Safety Notice (FSN) from Olympus Ireland (Ref: QIL FY24-EMEA-19-FY24-OMSC-19 UHI-4 Overpressure), this is a safety critical HSE National Patient Safety Alert. This alert is for action by all HSE Services that are using Olympus High Flow Insufflation Unit UHI – 4 (see Appendix A). UHI – 4 is used to facilitate laparoscopic and endoscopic observation, diagnosis, and treatment. It is used to insufflate the abdominal cavity and colon and provides automatic suction and smoke evacuation.

What is the issue?

This alert highlights a FSN that the medical device company Olympus has issued after it became aware of patients experiencing complications from over insufflation where UHI-4s were used, including arrythmias, gas embolism and one death. These complications may have been due to over insufflation of the abdominal cavity resulting from use of the UHI-4 during the procedures. This includes events where the device was reported to ‘not alarm’ or otherwise notify the user and events where the device did not relieve the over insufflation to the set pressure.

How to take action?

Circulate this HSE NPSA to relevant staff including but not limited to Clinical Directors, Surgeons, Anaesthetists, operators of the device, staff working in theatres and endoscopy units, managers of those areas and medical device engineers.
Alternative devices should be used where available
In the absence of an alternative device, the HSE recommends that extreme caution is exercised in the continued use of the Olympus UHI-4 device. Heightened vigilance is required through careful physiological monitoring for signs of complications.
If using a UHI-4 device the lead surgeons should conduct a call out – ‘insufflation commencing – please be extra vigilant ….’ to the attending anaesthetist during insufflation of the peritoneal cavity to allow hyper-vigilance to observe for bradycardias etc.
Please refer to pg.4 of the attached FSN for the action steps to be taken by end user
The risks associated with insufflation, with reference to the FSN should be included in the consent process.
Report any incident/near miss related to medical devices onto the National Incident Management System (NIMS), to the device manufacturer and the HPRA.

When does action need to be completed?

Please circulate this HSE NPSA to relevant staff by latest 27th November 2023.

Read the Full Alert

Why is this action required?

The medical device company Olympus became aware of patients experiencing complications from over insufflation during surgical procedures where UHI-4s were used. Olympus conducted a health hazard assessment, including an examination of adverse events and complaints. The assessment indicated that over insufflation may lead to various patient harms during a procedure, which may include gas embolism, arrythmias (bradycardia, asystole, or cardiac arrest), pneumothorax, kidney or urinary problems, hypoxia, subcutaneous emphysema, delay to treatment, more complex procedures. These complications could potentially lead to death.

A HSE Serious Incident Management Team [SIMT] was convened to review the FSN. The SIMT determined mitigating actions to reduce the likelihood of harm occurring based on a risk assessment, albeit, the root cause of the issue has not being determined yet. The decision to continue with the use of the UHI-4 at this time was taken due to absence of alternative devices and the greater risk of cancelling surgeries and procedures that involved use of a UHI-4 device.

What evidence supports the issuing of this HSE NPSA?

The Olympus health hazard assessment indicates that over insufflation may lead to various patient harms during a procedure which could potentially lead to death. Olympus is continuing a broader investigation for a root cause of over insufflation of the abdominal cavity in procedures which used the UHI-4. This includes concomitant devices, patient conditions and the specifics of the reported events, including an event where the user stated that the device did not alarm or otherwise notify the user and did not relieve the over insufflation to the set pressure. Olympus will update the HSE upon the conclusion of these investigations, including any further corrective actions necessary.

What stakeholders were involved in issuing this HSE National Patient Safety Alert?

This alert was developed collaboratively by the following:

HSE/RCSI Clinical Programme in Surgery
College of Anaesthesiologists of Ireland
HSE National Quality and Patient Safety Directorate
HSE Acute Operations
HSE Capital and Estates, National Medical Devices Office
Input from Health Products Regulatory Authority
HSE National Patient Safety Alerts Committee

References

Olympus Field Safety Notice (see attachment)
HSE Consent policy

Appendix A

According to the inventory list received from Olympus Ireland, the following hospitals are affected:

Beaumont Hospital
Cherry Orchard Hospital
Connolly Memorial Hospital
Letterkenny University Hospital
Louth County Hospital
Mater Misericordiae University Hospital
Mayo University Hospital
Mercy University Hospital
Midland Regional Hospital Mullingar
Midland Regional Hospital Portlaoise
Midland Regional Hospital Tullamore
Naas General Hospital
Our Lady of Lourdes Hospital Drogheda
Our Lady’s Hospital Navan
Roscommon University Hospital
Rotunda Hospital Dublin
Royal Victoria Eye & Ear Hospital
Sligo University Hospital
St Columcilles Hospital
St James's Hospital
St Lukes Hospital Clonmel
St Lukes Hospital Kilkenny
St Michael’s Hospital
St Vincent’s University Hospital
Tallaght University Hospital
Tipperary University Hospital
University Hospital Waterford
Wexford General Hospital

Download the alert as a PDF

What does it mean for me?

is a HSE NPSA supporting infographic that uses non-technical language in plain English to explain; what a HSE NPSA is, why it is being issued and what it means for patients, service users or their families.

It also outlines what (if anything) the patient, service user or their family may need to do if the alert is relevant to their care.

Olympus Field Safety Notice

Addendum Olympus Insufflation Unit UHI-4

Supplementary Letter Olympus Insufflation Unit UHI-4

Download the infographic 'What does it mean for me as a patient or service user?'

Download the HSE NPSA Local Action Plan

Back to HSE National Patient Safety Alerts