Product Liability

Hazard: If the device is repeatedly used (multiple times a day/week), the device can carry over bacteria or other pathogens from previous procedures.

Solution: Fully clean, sanitize, and disinfect the device after every single use. 

Hazard: Internal components like motors, batteries, and control boards can wear out overtime, which can significantly affect the operations of the device and lead to malfunction.

Solution: Certain components must have a lifetime based on testing while maximizing patient safety. Parts that are damaged should be documented immediately and be replaced before the next procedure the device is used in.

Hazard: The device is still subject to user error even if all of the components are working correctly. Errors do happen during surgery, and a robotic device can help mitigate errors, but not eliminate them.

Solution: Give effective training and allow for surgeons to practice with the device to make sure they understand certain strategies and techniques.