| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00100-1 |
| Product Name/Description |
High Flow Insufflation Unit UHI-4
ARTG 211802
(Olympus Australia Pty Ltd - Distension unit, gas, laparoscopic) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
12/04/2024 |
| Responsible Entity |
|
| Reason/Issue |
Olympus has become aware via both repairs and customer complaints of the “UHI-4 stopping CO2 gas supply with the front panel LED turning off”. Analysis of these complaints indicates this problem to be associated with a Control/CR board, pressure sensor circuit failure, and limited to devices manufactured before October 2019. If the UHI-4 detects a pressure sensor failure, the UHI-4 will raise an error. This error causes activation of the alarm, the front-panel LEDs turn off, and stops the CO2 supply. If this occurs before the procedure during set up, it may delay initiating treatment. In the event the UHI-4 CO2 supply stops during a procedure, the device becomes unusable.
Globally Olympus have received 41 complaints of a serious injury, (conversion to open surgery, arrythmias and respiratory problem/hypertension during surgery), and 2 reports of death related to the UHI-4 associated with both over pressurisation and CR board failure. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Olympus will perform the following corrections:
· Units manufactured before October 2019 will receive both software update and a CR Board Replacement.
· Units manufactured in or after October 2019 will only receive a software update.
Until these corrections are made, users should consider stopping use of this product unless the facility does not have or is unable to obtain an alternative device and chooses to use the UHI-4 with extreme caution, after weighing the potential benefits of the procedure over potential risk to health of over insufflation. |
| Contact Information |
1300 132 992 - Olympus Customer Operations |