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Model Number LF1937 |
Device Problems
Mechanical Problem (1384); Peeled/Delaminated (1454); Detachment of Device or Device Component (2907); Difficult to Open or Close (2921); Material Protrusion/Extrusion (2979)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/29/2023 |
Event Type
malfunction
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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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Event Description
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According to the reporter, during the dissection of the left gastric artery in a gastrectomy procedure, when sealed and dissected the space between hem-o-lock and hem-o-lock with the device, upon pulling the trigger, there was a crunchy feeling and when the jaws were opened, the seal was done, but a few white plastic pieces-like objects appeared. there was no patient injury.
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Manufacturer Narrative
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H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the unit had a damaged insulation.It was reported that the device had a component that disengaged, the knife blade of the device would not advance, the jaws of the device were difficult to open, and the insulation of the device was damaged.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.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: contact between an active instrument electrode and any metal objects (hemostats, staples, clips, retractors, etc) may increase current flow and may result in unintended surgical effects such as an effect at an unintended site or insufficient energy deposition.Do not engage the cutting mechanism over clips, staples, or other metal objects as damage to the cutter may occur.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 the dissection of the left gastric artery in a gastrectomy procedure, when sealed and dissected the space between hem-o-lock and hem-o-lock with the device, upon pulling the trigger, there was a crunchy feeling and when the jaws were opened, the seal was done, but a few white plastic pieces-like objects appeared. the plastic pieces were collected.There was no patient injury.
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Search Alerts/Recalls
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