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Model Number FGS-0636 |
Device Problem
Positioning Failure (1158)
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Patient Problems
Laceration(s) of Esophagus (2398); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/09/2022 |
Event Type
malfunction
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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, they had a capsule which failed to attach to the patient¿s esophagus and still attached to the delivery system upon removal.There was no any intervention performed as a result of the event.The patient had a small tear on esophagus.An endoscopy had been performed prior to the procedure and showed that the patient has a relative narrow esophageal lumen.Lubrication was used to facilitate the placement of the capsule.It was also reported that a repeat procedure was needed.
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Event Description
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According to the reporter, they had a capsule which failed to attach to the patient¿s esophagus and still attached to the delivery system upon removal.The patient had a small tear on esophagus but there was no intervention performed as a result of the event, and there was no second endoscopy required.An endoscopy had been performed prior to the procedure and showed that the patient has a relative narrow esophageal lumen.Lubrication was used to facilitate the placement of the capsule.Another capsule was used for the placement during the first procedure and there was no need for additional anesthesia.The patient is alive and healthy.
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Manufacturer Narrative
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New information has been received pertaining to the event.This event has been reassessed and the reportability has been determined to be a malfunction.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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Manufacturer Narrative
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Additional information: d9, g1 (manufacturer name, mfr contact first name, last name, street 2, mfr city, region, postal code, email and phone number), evaluation summary: medtronic conducted an investigation based upon all information received.The capsule and delivery system were returned for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that the capsule failed to attach to the patient's esophagus.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.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.
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Search Alerts/Recalls
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