According to the reporter, during a procedure, inability to complete sealing and bleeding were observed. the device constantly gave the warning that the sealing had been completed but sealing was not completed and the patient bled after cutting.The vessel was not fully transected using the first device, while vessel was fully transected on the second device.Bleeding observed directly from the seal.
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D10 concomitant products: lf1937, jaw lap lf1937 ligasure maryland 37cm, (lot #40380210x) vlls10gen, vlls10gen ls series vessel sealing gen, (sn: 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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