|
Model Number FGS-0313 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
|
Patient Problems
Chest Pain (1776); Dysphagia/ Odynophagia (1815); Discomfort (2330); Choking (2464); Radiation Exposure, Unintended (3164)
|
Event Date 07/05/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
Initial reporter occupation: na (other).If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According to the reporter, the capsule was placed in the esophagus without disclosing that the patient had a metal allergy and was experiencing chest pain which radiated to her back.It was noted that the patient was having dysphagia/choking prior to the procedure.A chest x-ray was performed and confirmed that the capsule is attached in the lower esophagus.The physician removed the capsule with a snare, nudged it into the stomach, and then removed it with a roth retrieval basket.There were no signs of an allergic reaction at the site.The patient reported an immediate improvement in her symptoms of chest discomfort, and demanded to keep the capsule in a container.However, it had already been sent to the pathology department and confirmed that it was a ph capsule.
|
|
Manufacturer Narrative
|
Corrected information: if information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|
|
|