Karl Storz C-MAC blades

ANZCA reminds fellows to inspect the C-mac blades for the presence of the optical window before, during and after use and as per the manufacturer’s instructions.

In 2019, Karl Storz issued a product defect correction notification, instructing hospitals/users to inspect all the C-mac blades in circulation to ensure the optical window was in situ. The Instructions for Use were also updated to provide guidelines on how to train and educate staff to inspect the C-Mac blades and to identify any degradation because of reprocessing and handling.

Users/hospitals who encounter the blade defect should report the incident to the:

• Reporting system of their organisation
• Manufacturer: Karl Storz at productcorrection@karlstorz.com.au
• National medical devices regulatory body:

1. Australia - TGA
2. New Zealand - Medsafe