| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00557-1 |
| Product Name/Description |
INTESTINAL VIDEOSCOPE OLYMPUS PSF-1, SINGLE USE POWERSPIRAL TUBE DPST-1 and POWERSPIRAL CONTROL UNIT PSCU
All lots
ARTG 114377
(OLYMPUS AUSTRALIA PTY LTD - Enteroscope, flexible, video)
ARTG 316691
(Olympus Australia Pty Ltd - Self-propelled endoscope spiral sleeve)
ARTG 314781
(Olympus Australia Pty Ltd - Power Control Unit - Endoscope workstation) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
29/06/2023 |
| Responsible Entity |
|
| Reason/Issue |
During a procedure on March 20th, 2023, the PSF-1 could not be extracted from the patient. The backward rotation of PowerSpiral withdrawal from the patient was unsuccessful. Manual unscrewing was also unsuccessful. The endoscope had to be surgically removed. On March 29th, it was informed that the patient died on March 24th, 2023, due to complications from the procedure. |
| Recall Action |
Recall |
| Recall Action Instructions |
Immediately cease use of and quarantine the device. The device should be returned to Olympus for refund. |
| Contact Information |
1300 132 992 - Olympus Customer Operations |