Endorail Set
ENDOSTART SRL · Model ESETGEN2V02A · UDI-DI 08057502310108
Description
Endorail includes two components to be used in combination called: Endorail Set and Endorail System. Endorail Set is disposable and includes the following elements: • Endorail Balloon Guide (EBG), • Endorail Solution Syringe (ESS), • Endorail Powder (EP), • Spike. Before the procedure, the operator prepares the syringe containing the ferromagnetic fluid using the ESS, the spike and the EP. The EBG is a balloon catheter that can be introduced as needed through the endoscope instrument channel during the colonoscopy, if the procedure becomes challenging. Endorail Set does not require to be pre-mounted and does not interfere with the normal examination process. The EBG is advanced beyond the colonoscope tip where the balloon is filled with the ferromagnetic fluid and magnetically anchored with the Endorail Handpiece (EH) placed on the patient’s abdomen. Once anchored, the colonoscope can be straightened and guided along the catheter. Afterward the EBG can be unlocked, deflated and retrieved.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-12 | Boston Scientific Corporation | Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button |
| 2026-02-12 | Olympus Corporation of the Americas | The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. |
| 2026-02-12 | Olympus Corporation of the Americas | The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. |
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