The endocapsule device (also known as the ¿capsule endoscope¿) has not returned to olympus for evaluation.The cause of the reported complaint cannot be confirmed.As a preventive measure, the endocapsule system manual contains several cautions addressing retention of the endocapsule, including these contraindications: ¿patients with known intestinal strictures, adhesions, diverticulum, obstruction, or fistulas that may block the passage of the capsule endoscope.Patients with these physical features risk retention of the capsule endoscope.¿ ¿patients who are nonsurgical candidates.Open surgery is required if the capsule endoscope is retained in the patient¿s body.¿ ¿patients with significant gastrointestinal tract delay.Long-term retention of the capsule endoscope may be observed in patients with known radiation enteritis due to intestinal strictures or adhesions.¿ and ¿patients who have an obstruction in their digestive tract as a result of past digestive bypass surgery.A patient who has undergone bypass surgery in the digestive tract usually has an obstruction that could result in retention of the capsule endoscope.¿ the system manual also warns, ¿patient safety has not been verified if the capsule endoscope remains within the patient¿s body for a period of 30 days or more.If excretion of the capsule endoscope has not been confirmed within 30 days after ingestion, conduct an x-ray examination in an attempt to locate the capsule endoscope.Once found, remove the capsule endoscope.¿ and ¿this device is mr unsafe.Instruct the patient to stay away from mri or other equipment that generates strong electromagnetic fields, between ingestion and excretion of the capsule endoscope.¿.
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Olympus was informed that a patient underwent an endocapsule internal examination on (b)(6) 2017, and that the endocapsule device was still in the patient when the user facility contacted olympus on dec.12, 2018 to inquire about mri compatibility with the device.It was reported that the patient had x-rays in (b)(6), (b)(6) and (b)(6) 2018 all confirming the continued presence of the device inside the patient.It was also reported that the user facility now plans to remove the device from the patient before attempting mri on the patient.There was no reported patient injury resulting from the retained device.
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