MEDTRONIC ADVANCED ENERGY (SALIENT) AEX GENERATOR-REFURB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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Model Number 40-405-1R |
Device Problem
Output above Specifications (1432)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Analysis summary: upon testing, the device was observed, and coag 8 was with in specifications.The specifications for coag 8 were 30.22 to 45.34.During investigation generator output was 38.However, there was operational - damage (functional).The white arrow was missing.Functional testing was done to address the complaint.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a healthcare professional (hcp) regarding a generator.It was reported that the generator was failing output testing.They were within speculation on the cut 8, cut 10, and coag 5, bit not on coag 8.They were getting an output of 90 when it should have been 38 +/-20%.There was no patient present as the issue was discovered during preventative maintenance (pm).
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Manufacturer Narrative
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Additional analysis summary performed: complaint confirmed: during functional testing of generator, the pcba failed and was replaced.Functional testing and calibration were performed to address the issue.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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