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Model Number FGS-0313 |
Device Problem
Entrapment of Device (1212)
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Patient Problems
Abdominal Pain (1685); Burning Sensation (2146); Discomfort (2330); Radiation Exposure, Unintended (3164)
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Event Date 11/05/2018 |
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 capsule was placed in the esophagus by endoscopy.The capsule caused a huge amount of pain, burning and discomfort as soon as it was in and it got progressively worse.The patient was unable to eat for 4 days due to the pain and swallowing the saliva was even very painful.The doctor had to endoscopically/ manually remove the capsule and push it into the patient¿s stomach to dislodge it.Since then, the patient had experienced a lot of nausea, abdominal pain, loss of appetite.It was also confirmed after an x-ray was performed that the capsule was still inside the patient.The patient had to go to the er because of discomfort due to the retained capsule.When the doctor removed the capsule, a "patch of white plaque" was seen near the area where the capsule was placed, and this was very unusual, so a biopsy was performed.The white plaque was not present on the first endoscopy, before the capsule was ingested.It appeared to be an allergic reaction to the capsule.The patient has had 2 endoscopies and one er visit within one week due to the capsule.
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Manufacturer Narrative
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Additional information: evaluation summary: the product sample was not returned to the medtronic laboratory; however, a picture was provided by the customer for analysis.The r eturned sample did not meet specification as received.The investigation identified the cause of the reported event to be could not be determined.A review of the appropriate device history records could not be performed.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 capsule was placed in the esophagus by endoscopy.The capsule caused a huge amount of pain, burning and discomfort as soon as it was in and it got progressively worse.The patient was unable to eat for 4 days due to the pain and swallowing the saliva was even very painful.The doctor had to endoscopically/manually remove the capsule and push it into the patient¿s stomach to dislodge it.Since then, the patient had experienced a lot of nausea, abdominal pain, loss of appetite.It was also confirmed after an x-ray was performed that the capsule was still inside the patient.The patient had to go to the er because of discomfort due to the retained capsule.When the doctor removed the capsule, a "patch of white plaque" was seen near the area where the capsule was placed, and this was very unusual, so a biopsy was performed.The white plaque was not present on the first endoscopy, before the capsule was ingested.It appeared to be an allergic reaction to the capsule.A file with pictures has been attached.The patient has had 2 endoscopies and one er visit within one week due to the capsule.The patient also received anesthesia twice within 4 days, due to the capsule needing to be removed.The patient also noted that the monitor did not work very well as it would randomly turn off.
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Manufacturer Narrative
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Evaluation summary: the product sample was not returned to the medtronic laboratory; however, a picture was provided by the customer for analysis.The attached picture did not identify anything that would have caused or contributed to the reported event.The investigation identified the cause of the reported event to be could not be determined.No update to the risk management file is required at this time.A review of the appropriate device history records could not be performed.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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