LUMENIS RECALLS DUOTOME SIDELITE DEVICES

Lumenis is recalling some of its DuoTome SideLite 550 Micron Delivery Systems after it shipped devices that lack markings to help surgeons position the instruments. The devices are used with laser systems in endoscopic urology procedures.

Black markings on the device's metal tip aid surgeons in positioning the device within the endoscope. The devices direct laser energy at an angle to remove soft tissue. The recalled devices still have an aiming beam to show where the energy exits, and a visible exit window, the company said.

While investigating the error, Lumenis said it also found reports of fiber degradation in the devices during use. Alone, these errors should not cause any significant problems, the company said.

The recall covers all Lumenis DuoTome SideLite 550 Micron Delivery System products manufactured since Feb. 1. The UK's Medicine and Healthcare products Regulatory Agency published the recall Oct. 10.