Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC
FDA device recall Z-0717-2024 · posted 2024-01-12 · Open, Classified
Recall details
- Recalling firm
- Olympus Corporation of the Americas
- Reason for recall
- The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile fiber stripper or cleaver on a sterile fiber poses a risk of contamination.
- Action taken
- An URGENT: MEDICAL DEVICE REMOVAL notification letter dated 12/4/23 was sent to customers. Actions to be taken by the end user: Our records indicate that your facility has received one or more affected units. Olympus requests you to take the following actions: 1. Examine your inventory and quarantine any devices with the lot number specified above. 2. Please contact Olympus customer service representative at 1-800-848-9024, option 2, with the quantity and model of affected devices. Olympus will issue a Return Material Authorization to return any affected product at no charge. Olympus will issue a credit to your facility upon return of affected product. 3. Access the Olympus recall portal to indicate that you have received this notification. a. Go to https://olympusamerica.com/recall. b. Enter the recall number "0435 c. Complete the form as instructed. 4. If you have distributed these devices outside your facility, please provide a copy of this letter to those facilities immediately. Olympus requests you to report any complaints, including product labeling issues, to our Technical Assistance Center (TAC) at 1- 800-848-9024, option 1, and the FDA. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. Olympus fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 or by e-mail at Cynthia.Ow@olympus.com.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- GEX
- Quantity affected
- 236 units
- Distribution
- US Nationwide. Global Distribution
- Date initiated
- 2023-12-04
- Date posted
- 2024-01-12
- Location
- Center Valley, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories) (K183647) | Olympus Surgical Technologies America | 2019-08-09 |