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Model Number 176657 |
Device Problems
Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Tissue Breakdown (2681); Unspecified Tissue Injury (4559)
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Event Date 04/14/2023 |
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.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, on a laparoscopic gastric bypass, there was tissue damage and tissue loss.A beige staple was used instead.
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Manufacturer Narrative
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Additional information: g3, h3, h6 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 instrument was partially fired with fourteen clips remaining.Functionally, the jammed clips were removed and the the instrument was cycled to load a clip and the jaws were no longer functioning properly.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 was 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.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, on a laparoscopic gastric bypass, during the clipping of a small residual stomach bleeding while in the stomach, the jaws of the device could not be opened and was stuck after firing.The surgeon had to pull the device off with force.A beige staple was used to step off of the part of the stomach.There was tissue loss and temporary tissue damage.The surgeon stacked a part of the stomach to remediate the tissue damage.
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Event Description
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According to the reporter, on a laparoscopic gastric bypass, during the clipping of a small residual stomach bleeding while in the stomach, the jaws of the device could not be opened and was stuck after firing.The surgeon had to pull the device off with force.A beige staple was used to step off of the part of the stomach.There was tissue loss and temporary tissue damage.The surgeon stacked a part of the stomach to remediate the tissue damage.
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Manufacturer Narrative
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Additional information: b5, e1 (facility name, street 1, city, country), g3, h6 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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