COVIDIEN MFG DC BOULDER VALLEYLAB FT10; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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Model Number VLFT10GEN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Burn(s) (1757); Uterine Perforation (2121)
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Event Date 03/14/2024 |
Event Type
malfunction
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Manufacturer Narrative
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D10 concomitant product: e0510, e0510 footsw monop cord diam 4mm-3mx50 (lot#unknown).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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According to the reporter, during a lap removal of adnexal/ovary, a non-medtronic device was being used with the generator and cord.At the point where the microphone disposable attached to the instrument melted which caused a burn and perforation of the uterus.When instrument was removed everything appeared to be connected properly.The perforation was sutured and additional hospital stay was not required.
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Manufacturer Narrative
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Additional information: g3 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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