Medical Device Electrical Issue

Issue associated with the use of the device in terms of user experiencing difficulty in preparing the device for use, even if…

Issue associated with any deviations from device documented performance specifications relating to the sequence of events for activation and positioning of the…

The act of instantiating, positioning or activating a medical device inside of the body.

Issue associated with the device being received in such a manner to indicate that its sterility has been compromised (e.g. sterile packaging…

Issue associated with the undesired introduction of impurities either chemical or microbiological in nature, or of foreign matter into or onto the…

Issue associated with the presence of any unexpected foreign substance found on the surface or in the package materials, which may affect…