What are some examples of adverse events that would not have / have to be reported?
A patient is sent to have a colonoscopy as a diagnostic test for cancer. The colonoscopy itself is uneventful, but the mass is biopsied and determined to be cancerous. The patient is admitted to a hospital for further testing and treatment. The hospitalization is not related to the OBS procedure itself, but rather to the results of the diagnosis revealed from the procedure. This would not need to be reported. A patient has a routine colonoscopy, which is uneventful. The next day, the patient suffers a gall bladder attack and is admitted to the hospital. Since the hospitalization is completely unrelated to the colonoscopy, this would not need to be reported. A patient has a routine colonoscopy, during which the surgeon perforates the colon. The patient must be transferred to a hospital on an emergency basis. This would need to be reported. A patient is given deep sedation that appears appropriate for the patient’s age, physical condition, etc. During the procedure, the anesthesiologist
