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AdvanCE
US Endoscopy · Model 00711144 · UDI-DI 00724995183608
NEZ
Prescription
10
510(k) clearances
731
Adverse events (24 deaths)
6
Recalls
16
Facilities
Description
The disposable AdvanCE capsule endoscope delivery device is a 2.5mm single sheathed device indicated for transendoscopic delivery of Capsules (with the dimensions of 10.5mm - 11.5mm in diameter and 23.5mm - 26.5mm in length), to the stomach or duodenum. This device is intended for patients who are either unable to swallow the capsule, or unable to pass the capsule beyond the pylorus in sufficient time to complete the desired diagnostic evaluation.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-02-26 | Capso Vision, Inc. | Ingestible video capsule system has capsule with incorrect capture mode which will not record data when the capsule is ingested by patients. If used, there is a risk of delay of di |
| 2019-10-18 | Capso Vision, Inc. | Capsule Endoscopy System: a defect present in the capsule window may be stressed through the production process and in the final package, which could cause the housing of the capsu |
| 2019-07-03 | Capso Vision, Inc. | Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdiagnosis. |
| 2017-02-15 | IntroMedic Co., Ltd. | When a user switches on MR1100 Receiver, even though the battery was fully charged, the LED was displayed as orange color due to momentary drop of battery voltage. |
| 2011-03-08 | Given Imaging Ltd. | The capsule holder can break away from the catheter during endoscopic procedures, necessitating retrieval. |
| 2007-12-13 | Given Imaging Inc | The cards included in the product's education kit (proposing a clinical algorithm for capsule endoscopy in patients with suspected Crohn's disease), were printed incorrectly. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.