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Video telescope - endoeye hd ii
Official notice
27 Nov 2023
Last checked
27 Nov 2023
An official Health Canada notice concerns 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 Published 2023-11-27.
What to do now
Contact the manufacturer if you require additional information.
Recall number
74656
Official notice
2023-11-27
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.
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Where it was sold
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Company & contacts
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Brand: Olympus Winter Ibe, Video Telescope - Endoeye HD Ii.
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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