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Model Number UNKNOWN TRICUT BLADE |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pneumothorax (2012); Injury (2348); Radiation Exposure, Unintended (3164)
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Event Type
Injury
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Event Description
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It was reported to medtronic that a physician was notified by a colleague, that sometime within the past 10 years the following account occurred when a microdebrider was being used with the tricut blade: a patient developed ¿subcutaneous emphysema, right pneumothorax and pneumomediastinum after jet ventilation and use of a microdebrider for excising tracheal papilloma.The patient awoke from anesthesia without shortness of breath or evidence of hypoxia.On routine chest x-ray the right pneumothorax and pneumomediastinum were diagnosed.Conservative measures were taken and the radiologic findings resolved spontaneously and the patient was observed.The chest ct did not reveal a tracheal defect, however it was agreed the pattern of airflow suggested a breach of the anterior tracheal wall.It was suggested that a small mucosal tear spontaneously resolved after jet ventilation ceased.¿ the doctor has confirmed that no additional information is available.
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Manufacturer Narrative
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This device is used for therapeutic purposes.Concomitant medical products: 1898200t: microdebrider, 1898200t igs m4, 510k: k041413, erl.(b)(4).Product evaluation: no analysis results available.Devices will not be returned for evaluation.Method: no testing methods performed.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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