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Model Number 176630 |
Device Problem
Entrapment of Device (1212)
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Patient Problem
Unspecified Tissue Injury (4559)
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Event Date 02/16/2023 |
Event Type
Injury
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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.
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Event Description
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According to the reporter, during a laparoscopic radical nephrectomy procedure, at the time of cutting the vessel, upon firing the clip applier, the device jammed, clamped on the vessel, and was unable to release.It was noted that there was tissue damage.To resolve the issue, they had to use a different clip applier on either side and cut the clip applier out while still attached to the vessel.
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Event Description
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According to the reporter, during a laparoscopic radical nephrectomy procedure, at the time of cutting the vessel, upon firing the clip applier, the device jammed, clamped on the vessel, and was unable to release.The surgeon was unable the squeeze the handle.It was noted that there was tissue damage.To resolve the issue, they had to use a different clip applier on either side and cut the clip applier out while still attached to the vessel.
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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.
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Manufacturer Narrative
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H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted the jaws of the instrument were clamped with two fully formed clips caught between the jaws.Functionally, the handle could not be actuated to complete the cycle.The lodged clips were removed from the jaws of the instrument; the handle cycle could be completed.The instrument was then applied to appropriate test media.Fourteen clips advanced into the jaws, formed properly, and were held securely in place after full formation was achieved and the firing handle was released.When the cartridge was empty, the interlock engaged to prevent the jaws from approximating.It was reported that the jaws of the device remain closed on tissue.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur if an attempt is made to apply a clip over a fully formed clip or obstruction.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: prior to placing a clip, confirm that the jaws are positioned free of other clips or obstructions.Placing the jaws or firing the instrument over another clip or other obstruction may result in bleeding and or lack of hemostasis and or damage to the instrument jaws.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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