Unofficially notified investigation – instruments

Unofficially reported inspection – Instruments (F-86-C)

Product performance data for the past year – Instruments (F-86-C). In the absence of exact figures, an estimated value can be provided (if the question is not relevant, please leave it blank).

Unofficially reported test data

Partner company:

Exact type of instruments concerned:

Number of tools used:

Number of patients:

Feedback date:

Number of instruments successfully used

Number of cases where an adverse reaction/complication occurred

Type of instruments involved in adverse reactions/complications

Distribution of side effects by type

Thrombosis, embolism:

Excessive bleeding:

Nerve and vessel damage:

Soft tissue damage (swelling, abnormal wound formation):

Allergy or hypersensitivity:

Musculo-skeletal functional impairment

lack of bone healing or inadequate bone healing

Acute anaemia

Septic shock

Device breakage, cracking

Device deformation

Overheating

A usage error related to the use of the device

Other:

Device incident count

Device breakage, cracking:

Tool deformation:

Usage error related to the application of the device:

Other:

Were the assets exposed to extreme stress?

yes no

Way of extreme stress

Other comments, ideas, observations