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Olympus
OLYMPUS Winter & Ibe GmbH · Model A5150.1 · UDI-DI 04042761007498
GCP
Prescription
10
510(k) clearances
697
Adverse events
5
Recalls
16
Facilities
Description
Needle, acc. Veress, 150 mm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-11 | Olympus Corporation of the Americas | Complaints of the ceramic tip of the resection sheath breaking have been received. |
| 2024-09-13 | Olympus Corporation of the Americas | Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from the Instruction for Use (IFU) due to the potential for a damaged tip during use of a |
| 2024-09-13 | Olympus Corporation of the Americas | Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device. |
| 2017-08-18 | Olympus Corporation of the Americas | Olympus has received complaints about fragments of adhesive which detached from inside the working channel of the referenced products. Cracking, chipping, missing pieces, and delam |
| 2017-04-19 | Olympus Corporation of the Americas | Loop wires breaking at the distal end of the Monopolar HF Resection Electrodes. |
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