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Model Number FGS-0636 |
Device Problem
Separation Failure (2547)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/09/2023 |
Event Type
malfunction
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Manufacturer Narrative
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D10 concomitant product: fgs-0636 - fgs-0636 cf delivery dev caps bravo x1, lot# 58017f 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, pre-use checks for the first delivery device was completed prior to procedure, and there were no issues noted during pre-use checks.The physician inserted the device through oral cavity and confirmed it was in esophagus via endoscope.The physician deployed the capsule as instructed, then the delivery device was removed from patient with no resistance.Once removed, the capsule appeared to be loosely dangling off of delivery device, and fell onto floor once removed from oral cavity, without physical manipulation.The customer then obtained a new delivery device from same lot number as the first capsule and completed same pre-use checks, and there were no concerns.The physician completed same steps for capsule deployment, then upon visual confirmation that capsule had adhered to esophagus, the capsule appeared to be located in the patient's stomach and not attached to mucosa (free moving).The physician decided to leave capsule in place, to pass via gastrointestinal tract as capsules normally do for this procedure.The delivery device was removed from patient via oral cavity.The physician did not make a third attempt.There was no patient or user harm.
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Manufacturer Narrative
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Evaluation summary: medtronic conducted an investigation based upon all information received.The delivery system was not returned, but the capsule was available for evaluation.Visual inspection noted the capsule needle was advanced by the push wire of the delivery system.A comprehensive examination could not be performed, because the returned sample was not received in a state that allowed full functional or visual assessment.It was reported that the capsule failed to detach from the delivery system.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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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