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Model Number GN-283 |
Device Problems
Break (1069); Detachment of Device or Device Component (2907)
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Patient Problems
Foreign Body In Patient (2687); Unintended Radiation Exposure (4565)
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Event Date 07/08/2022 |
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.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 total gastrectomy, when the 2-0 purse-string needle was used for anastomosis, the 3 mm front of the needle was broken.The needle was left in the abdominal cavity.The needle was searched in many places by many people and was reported to the head nurse.The radiology department was contacted for many times and the broken needle was not found in the abdominal cavity and thoracic cavity.The abdomen was closed as ordered by the doctor.The x-ray film was kept, and the surgeon informed the family of the event.
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Search Alerts/Recalls
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