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Model Number 176630 |
Device Problems
Entrapment of Device (1212); Mechanics Altered (2984)
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Patient Problem
Unspecified Tissue Injury (4559)
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Event Date 07/27/2021 |
Event Type
Injury
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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, intra-operatively of a laparoscopic sleeve gastrectomy, the surgeon attempted to control a minor bleeding by using a clip.The clip was deployed but the device did not release the clip.The device could not be detached and removed from the patient which resulted to an additional gastric resection.
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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, intra-operatively of a laparoscopic sleeve gastrectomy, the surgeon attempted to control a minor bleeding by using a clip.The clip was deployed but the jaws of the device could not be released from the tissue.The jaws could not be pried open with other instruments.The device could not be detached and so additional gastric resection was required to remove it from the patient.Another device was used to complete the case.
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Manufacturer Narrative
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Medtronic conducted an investigation based upon all information received.Three photos and one device was returned for analysis.Visual inspection noted the jaws of the instrument were clamped with a row of staples in tissue caught in a clip.The handle was partially actuated.Functional evaluation noted the lodged tissue and a row of staples were removed from the jaws of the instrument.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.A review of the device history record indicates the product was released meeting all medtronic quality release specifications at the time of manufacture.The reported condition was confirmed.The analysis noted evidence that the device was not used as intended.Replication of the observed condition may occur if an attempt is made to apply a clip over a fully formed clip or obstruction.Instruction for use (ifu) states: 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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