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Model Number 134051 |
Device Problems
Entrapment of Device (1212); Fail-Safe Problem (2936); Mechanics Altered (2984)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/17/2021 |
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, in the blood vessel on a hepatectomy, two devices were also not loading properly into the jaws, also, the handle cannot be squeezed on second firing.The jaws of the devices lock on tissue and was released as usual.To resolve the issue, a new clip applier was used.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 plate latch was found to be out of specification.The reported issues were confirmed.The most likely root cause was traced to a component failure.The most likely cause was determined to be component failure.The plate latch was noticed to be at inside of lower housing without free movement (up/down) with latch spring component.This restricted pivoting movement could result in the observed failure conditions.Internal process improvements have been initiated to address this issue.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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