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Type of Product	Medical Device
TGA Recall Reference	RC-2024-RN-00237-1
Product Name/Description	POWERSEAL Sealer and Divider Model number: PS-0523CJDA Lot number: CA182554 Model number: PS-0537CJDA Lot number: CA182543, CA182544, CA182546, CA182548, CA191230 Model number: PS-0544CJDA Lot number: CA179370 ARTG 371990 (Olympus Australia Pty Ltd - Laparoscopic electrosurgical forceps, bipolar)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	25/03/2024
Responsible Entity	Olympus Australia Pty Ltd
Reason/Issue	Olympus has become aware of nine (9) POWERSEAL units determined to be out of specification which may have resulted in the device not performing as expected. Olympus has received one (1) complaint of malfunction associated with the problem for these lots. The root cause of the problem was identified and corrected in early 2022.
Recall Action	Recall
Recall Action Instructions	Customers should: 1. Inspect inventory and identify any affected products. Please check all areas of the hospital to determine if any of these devices remain in inventory. 2. Quarantine and cease use of the affected model/lots. 3. Complete the reply form in the customer letter and Olympus will issue a credit to your facility upon return of the affected product. 4. If you have distributed these devices outside your facility, identify your customers and alert them to this recall.
Contact Information	1300 132 992 - Olympus Customer Operations