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Model Number FORCETRIAD |
Device Problem
Electrical Shorting (2926)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/16/2021 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, during the procedure, the surgeon felt a bitter/tingling stimulation.After checking the pencil after the procedure, a crack was found in the pencil.Pencil, return electrodes, etc.Are products from other companies.As there was concern about electric leakage, inspection will be performed at tsc.Only the doctor felt the stimulus at that time.The doctor confirmed that he was not seriously burned.The procedure was completed without any problem.There was no patient injury.
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Manufacturer Narrative
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Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted no observable conditions.Functional testing found no issue with the generator that could be attributed to the surgeon feeling a bitter/tingling sensation or high leakage current.It was reported that the device had current leakage.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: the unit had a fan failure.The most likely cause for the additional condition is traced to a component failure.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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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Manufacturer Narrative
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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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Search Alerts/Recalls
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