| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00824-1 |
| Product Name/Description |
High Flow Insufflation Unit
Part number: UHI-4
All serial numbers
ARTG 211802
(Olympus Australia Pty Ltd - Distension unit, gas, laparoscopic) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
6/10/2023 |
| Responsible Entity |
|
| Reason/Issue |
Olympus has become aware of patients suffering adverse events duringsurgical procedures that may have been due to over insufflation of theabdominal cavity.
Over insufflation may lead to various patient harms during a procedure including air embolism, arrythmias (bradycardia, asystole, or cardiac arrest), pneumothorax, kidney or urinary problems, hypoxia, subcutaneous emphysema, delay to treatment, more complex procedures, and potentially death. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are advised:
1. If over insufflation of UHI-4 unit is observed in the operative field i.e., the pressure in the cavity exceeds the set pressure without resolution, discontinue use, replace the equipment with an alternative, and notify Olympus.
2. After turning the power on, confirm all indicator lamps light for two seconds and three tones sound. If the indicator lamps faul to light for two seconds or three tones fail to sound, equipment may be faulty and Olympus must be contacted.
3. Use the lowest intraabdominal pressure allowing adequate visualisation of the operative field for the procedure.
Further instructions are supplied in the customer letter appendix and IFU addendum which is supplied to all affected customers. |
| Contact Information |
1300 132 992 - Olympus Customer Operations |