GIVEN IMAGING LTD., YOQNEAM PILLCAM; SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
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Model Number FGS-0668 |
Device Problem
Entrapment of Device (1212)
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Patient Problems
Abdominal Pain (1685); Radiation Exposure, Unintended (3164)
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Event Date 08/12/2020 |
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, the patency capsule was still present inside the patient's cavity.An imaging was performed twice and they confirmed the capsule location.Patient was also complaining of abdominal pain.Patient had a diagnosis of crohn's disease.The medical safety team saw from the imaging a small metallic radio-frequency identification (rfid) tag in the lower right quadrant area and no evidence of bowel obstruction.The capsule already passed on its own after 7 days.
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Manufacturer Narrative
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Additional information: b5, g4.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, the patency capsule was still present inside the patient's cavity.An imaging was performed twice and they confirmed the capsule location.Patient was also complaining of abdominal pain.Patient had a diagnosis of crohn's disease.The medical safety team saw from the imaging a small metallic rfid tag in the lower right quadrant area and no evidence of bowel obstruction.The capsule already passed on its own after 7 days.
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Manufacturer Narrative
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Additional information: g4, h3, h6.H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted that the capsule was retained in patient.It was reported that the capsule remained in the patient longer than expected.The reported issue was 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.The instructions included with this device provide the following guidance: patients with suspected or known intestinal strictures may be at increased risk for bowel obstruction due to impaction of the intact patency capsule at the site of the narrowing or stricture, particularly during the first 1-2 days after capsule administration.Should this occur, patients may require bowel decompression until the capsule disintegrates or surgical intervention, if symptoms persist.Patients should be made aware of the signs and symptoms of bowel obstruction (abdominal pain, nausea, vomiting, and distention) and be advised to contact their physician should these symptoms occur anytime between capsule ingestion and documented excretion.Patients should also be informed that surgical intervention may be required if obstruction were to occur.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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