COVIDIEN MFG DC BOULDER VALLEYLAB FT10; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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Model Number VLFT10GEN |
Device Problems
Energy Output Problem (1431); No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/30/2023 |
Event Type
malfunction
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Event Description
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According to the reporter, during a procedure, the device was not sealing the tissue (no evidence of energy delivery).There was no patient injury.
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Manufacturer Narrative
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D10 concomitant product: lf1837, blunt tip sealer divider lf1837 (lot#31710225x).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 total laparoscopic hysterectomy (tlh), the device was not sealing the adnexa tissue (no evidence of energy delivery), no re-grasp alert and no end tone.It was random.The tissue was in normal thickness.Another device was opened and it worked fine.There was no patient injury.
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Manufacturer Narrative
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Additional information: g3 correction: b5, h6 (rfr updated) new information has been received, and reassessment of the complaint found that it is no longer a reportable event.The event is no longer associated with a serious injury or potential for serious injury with reoccurrence.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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