Video Telescope - Endoeye HD II

Olympus has identified a total of 1003 complaints, including 372 adverse events (since September 2020 to August 2023) related to pink or green coloration of the image, including cases with reported delays of treatments and/or prolonged surgery. Olympus investigated the complaints and identified that the CCD chip that produces the image became damaged. The CCD chip is sensitive to heat and mechanical shocks. Olympus's risk management is taking this into account, and the instructions for use mention necessary steps to prepare the video telescope prior to usage. This medical device recall has been launched to remind customers to follow the steps in the instructions for use, especially to inspect the image prior to a clinical procedure, and always have a spare laparoscope available. 

Recall start date: November 8, 2023