According to the reporter, during a procedure, the device¿s jaw had exposed wire.As surgeon was using device there was a small component or extrusion that was sticking up slighting in the butt of the jaws that was catching tissue.Another device was used successfully with the same generator.There was no patient injury.
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D10.Concomitant product: vlft10gen, vlft10gen ft series energy platformx1.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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