| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00860-1 |
| Product Name/Description |
EVIS X1 VIDEO SYSTEM CENTER OLYMPUS
Product code: CV-1500
Serial numbers: SN7000617 to SN7353298
ARTG 216644
(Olympus Australia Pty Ltd - Light source/processing unit, endoscope) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
5/10/2023 |
| Responsible Entity |
|
| Reason/Issue |
Olympus has received a complaint that the water delivery tube came in contact with the touch panel and the Air flow button was unintentionally turned on. This resulted in an adverse event and the patient had a pneumothorax due to the air insufflation during the Peroral Endoscopic Myotomy, POEM procedure.
Unintentional contact with the touch panel may result in the activation of unintended functions which could cause patient symptoms or injuries that include abdominal distention, procedure delays, pneumothorax, air embolism, or tissue injury. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are to utilise the Lock touch panel function for all procedures. The detailed operation of this function is explained in section 5.12 of the instruction manual and reproduced in the appendix of the customer letter (supplied to affected customers by the sponsor).
Customers are to closely follow the warning section in the updated instruction manual (supplied to customers in the customer letter), which informs users to keep objects away from the touch panel. |
| Contact Information |
1300 132 992 - oaz-fca@olympus.com - Olympus Australia |