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Model Number LF2019 |
Device Problems
Device Alarm System (1012); Retraction Problem (1536); Difficult to Open or Close (2921)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/16/2024 |
Event Type
malfunction
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Event Description
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According to the reporter, during an axilory mastectomy procedure, the handpiece was used previously a couple of times without issue.Then it indicated that the seal was not complete when used.On closer inspection, the blade was seen to not be retracted as in normal use and the jaws eventually opened after multiple trials.The handpiece was then substituted for a new device and no further issues were noticed.There was no patient injury.
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Manufacturer Narrative
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D10 concomitant product: vlft10gen, vlft10gen ft series energy platformx1, (sn: 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.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 an axilory masectomy procedure, the handpiece was used previously a couple of times without issue.Then it indicated that the seal was not complete when used.On closer inspection while being cleaned, the blade was seen to not be retracted as in normal use and the jaws eventually opened after multiple trials.The device was cleaned regularly with a wet gauze.The knife blade did not extend nor protruded beyond the edge of the jaws.The handpiece was then substituted for a new device and no further issues were noticed.There was no patient injury.
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Manufacturer Narrative
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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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Manufacturer Narrative
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Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the cutting blade was stuck in the advanced position, due to eschar.Functionally, the device's jaw opening and closing mechanism was functioning properly.The weld integrity of the device was inspected and was found to be within specification.The blade moved smoothly along the knife track and returned to the home position when the trigger was released, once the device was cleaned.The knife cut of the device was tested on a silicone test strip with acceptable results.The heel gap of the device was measured and it was found to be within specification.The device was activated multiple times on a saline soaked gauze pad with satisfactory results.All seal cycles were completed satisfactorily and end tones were heard indicating completed activation cycles.No electrical or wiring issues were found.It was reported that there was an alarm activation issue.The reported issue could not be confirmed.The most likely cause could not be established from the information available.It was also reported that the knife was difficult to retract.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur when the device is improperly cleaned.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: keep instrument jaws clean.Build-up of eschar may reduce the seal and/or cutting effectiveness.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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Search Alerts/Recalls
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