The patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
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It was reported to boston scientific corporation that an interject¿ needle was used in the esophagus during a gastroscopy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the channel was blocked and no adrenaline could be pushed through.The procedure was completed with another interject¿ needle.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
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