Field Safety Notice Olympus UHI-4 High Flow Insufflation Unit (ICN 2375)

Alert:

• Olympus has released a Field Safety Notice relating to UHI-4 High Flow Insufflation Unit products.
• There are three product codes affected.
• Olympus has become aware of patients experiencing complications from over-insufflation where UHI-4s were used. Clinical complications cited from Olympus include “short cardiac arrest gas embolism and one death during surgical procedures where the UHI-4 has been used.
• These complications may have been due to over-insufflation of the abdominal cavity resulting from the 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.

 Products Affected:          

• The affected products are not available via the NHS Supply Chain catalogue.
• These capital products are purchased via OJEU (Official Journal of the European Union) compliant orders using our Unique Reference Number (URN) requested from the buying team.

Next Steps

• See our Downloads ▼ section to access the full instructions in the Field Safety Notice and share them with all users of the affected products.
• Follow local organisational risk assessment.
• You should take the following actions:
  1. Discontinue use of the UHI-4 until the root cause investigation is completed
  2. Devices should be quarantined and marked appropriately by your site to prevent usage
  3. If your facility does not have alternatives or is unable to obtain alternatives, you may choose to use the UHI-4 while exercising extreme caution, after weighing the potential benefits of the procedure versus the potential risk to the health of over-insufflation.
  4. If your organisation determines option 3, please ensure staff are made aware of Pages 2 and 3 of the Field Safety Notice CONSIDERATIONS FOR PROVISIONAL USAGE and is applied in addition to patient procedure risk assessment.
• Olympus requests that you report complaints, including any injuries associated with over-insufflation during the procedure with UHI-4, to Olympus.
• Please report complaints to concerns@olympus.co.uk
• If you require additional information, please do not hesitate to contact the supplier at ra@olympus.co.uk
• If you have any further questions, please contact your local NHS Supply Chain Hospital Care team.