Model Number UNKNOWN TRICUT BLADE |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Low Oxygen Saturation (2477); Skin Tears (2516)
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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 case involving use of the microdebrider for an obstructing squamous cell carcinoma resulted in an anterior subglottic tear causing the patient to undergo urgent tracheostomy.The patient was decannulated shortly thereafter and was able to resume planned treatment with chemoradiation without delay of therapy.¿ 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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