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); 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: ¿patient with extensive laryngeal papilloma developed a massive hemorrhage during use of the microdebrider requiring intraoperative laryngeal packing to stabilize the patient prior to angiography after endoscopic measures to control the bleeding were unsuccessful.The patient was intubated for four days before the packing was removed in the operating room.The patient did well without permanent sequelae.¿ the doctor has confirmed that no additional information is available.
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Manufacturer Narrative
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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.(b)(4).
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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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