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Model Number VLFT10GEN |
Device Problems
Energy Output Problem (1431); Insufficient Information (3190)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
malfunction
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Manufacturer Narrative
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Concomitant prod: lf2019 (exact dissector lf2019 ligasure 21cm, lot number: unknown) 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.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 a hemorrhoidectomy, while sealing hemorrhoidal tissue with 3-4mm¿s thickness, the device had no re-grasp alert, end tone was heard and there was evidence of energy delivery.The device partially sealed the tissues, the jaw was cleaned each time it didn¿t work, several times, no good seals were completed.There was more bleeding occurred than usual (80-100mls), no blood transfusion was required.
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Manufacturer Narrative
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New information has been received, and reassessment of the complaint found that it is no longer a reportable issue.The event is no longer associated with a serious injury or potential for serious injury with reoccurrence.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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Event Description
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According to the reporter, during a hemorrhoidectomy, while sealing hemorrhoidal tissue with 3-4mm¿s thickness, the device had no re-grasp alert, end tone was heard and there was evidence of energy delivery.The device partially sealed the tissues, the jaw was cleaned each time it didn¿t work, several times, no good seals were completed.There was more bleeding occurred than usual (80-100mls), no blood transfusion was required.There was no previous experience that did not seal.Previous experience was a positive one as it seals correctly.
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Search Alerts/Recalls
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