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Model Number 134031 |
Device Problems
Detachment of Device or Device Component (2907); Mechanics Altered (2984)
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Patient Problems
Foreign Body In Patient (2687); Unintended Radiation Exposure (4565)
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Event Date 03/04/2021 |
Event Type
Injury
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Manufacturer Narrative
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The incident device has been received and is under evaluation.When the device evaluation is complete a follow-up report will be submitted.(b)(4).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 procedure, two units of reported clip applier had malfunctioned.The clips could not be placed correctly, and fell into the patient's abdominal cavity, which then had to be searched for.Clips could have remained in the patient's abdomen (without any function) and could have caused an infection.
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Manufacturer Narrative
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H3 evaluation summary: medtronic conducted an investigation based upon all information received.Two opened and five sealed devices were available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that the clips did not load properly into the jaws as expected, a component disengaged from the device into the surgical cavity, and there was significant surgical intervention was required due to the product failure.The reported issues could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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 laparoscopic procedure, two units of reported clip applier had malfunctioned.The clips could not be placed correctly, and fell into the patient's abdominal cavity, which then had to be searched for.An x-ray was performed to locate the component and it was retrieved.The user took a device from the competitor to resolve the issue.
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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 a laparoscopic procedure, the clips could not be placed correctly, and fell into the patient's abdominal cavity, which then had to be searched for.An x-ray was performed to locate the component and it was retrieved.The user took a device from the competitor to resolve the issue.
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Search Alerts/Recalls
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