THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope
THD SPA · Model THD Light - Scope LED Medium Rectoscope Not Sterile · UDI-DI 08033737710449
10
510(k) clearances
697
Adverse events
5
Recalls
16
Facilities
Description
The Light-Score LED rectoscope is a disposable medical device deemed for investigation of the anal canal and of the distal region of the sigma. The Light-Score LED rectoscope combines in a single device a magnifier lens and a powerful, fully integrated, LED light source, in order to have a clear and detailed vision of the inspection field. The Light-Score LED rectoscope is ready-to-use and it also available with an inflating included.
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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.