| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00340-1 |
| Product Name/Description |
InstaClear Sheath
Multiple Products, Catalogue Numbers and Lot Numbers
ARTG 274549
(Olympus Australia Pty Ltd - Guard, instrument) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/05/2024 |
| Responsible Entity |
|
| Reason/Issue |
After investigating a complaint associated with an InstaClear Sheath (Model # LCS4K30BTOL) in which the plate on the distal end of the sheath broke during a procedure, Olympus is initiating a Product Defect Correction to update instructions in relation to the use of Olympus InstaClear Sheath devices.
The pin or plate breaking off the tip of the InstaClear sheath can lead to potential patient harms such as: delay in initiating a procedure or a foreign body (broken pin or plate) in the patient, potentially requiring imaging and prolonged operative time.
Additionally, tissue injury or bleeding could occur due to exposed sharp edges. A broken piece remaining in the patient could potentially lead to an inflammatory reaction (granuloma), or infection.
Globally, since the product was launched in 2016, four (4) complaints were reported as serious injuries. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are to be aware of the Addendum to the IFU providing updated instructions for sheath installation and setup including warnings to inspect the sheath upon removal from patient to determine any missing components and to immediately retrieve any fragments retained within the patient.
Olympus encourages customers to report any malfunctions, including adverse events and injuries associated with any Olympus devices to oaz-feedback@olympus.com and to the TGA for investigation. |
| Contact Information |
1300 132 992 - oaz-fca@olympus.com - Olympus Customer Operations |