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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
Hemorrhage/Bleeding (1888); Low Oxygen Saturation (2477)
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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: when ¿using endoscopic microdebridement for laryngotracheal carcinoma, there was one intraoperative hemorrhage in a coagulopathic patient requiring emergent tracheotomy for intraoperative bleeding.It is unclear if the microdebrider was the ultimate cause of bleeding.¿ 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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