Concomitant product: vlft10gen - vlft10gen ft series energy platformx1, 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.
|
According to the reporter, during procedure, activation and end tone were heard but sealing was inadequate/partial.There was an error code of incomplete seal given without energy being activated.Bleeding was not observed directly from the ligasure seal.Another ligasure was used with the same generator and it worked fine.There was no patient injury.
|