According to the reporter, prior to use, the handpieces that were connected to the generator with software version of 4.0.4 had an error 420 code. the devices had not been reprocessed or remanufactured.There was no patient involvement.Medtronic's initial evaluation of the incident device found an ft10 generator software issue related to the customer's operating software version in which the authentication check gives an incorrect error message.
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D10: concomitant product/s: lf1937, jaw lap lf1937 ligasure maryland 37cm, (lot #32350308x) lf1937, jaw lap lf1937 ligasure maryland 37cm, (lot #33050382x) lf4418, open sealer lf4418 curved large jaw, (lot #32770254x) lf4418, open sealer lf4418 curved large jaw, (lot #32400312x).Medtronic conducted an investigation based upon all information received.The device data was available for evaluation.An evaluation was led of a vlft10gen for a non-reportable condition involving an error message with a ligasure device.During the investigation, a generator software issue was identified as being related to the reported error message in which this error message may occur when the vlft10gen generator performs an authentication check to confirm that the ligasure instrument has not been used previously.This identified software issue has a potential for patient harm.Software enhancements have been implemented to mitigate this condition.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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