EZDILATE BALLOON DILATOR (FW) 18-19-20
Received Jul 27, 2026 · Event occurred Jun 24, 2026
Report 3011050570-2026-00760 · MDR key 50012399
Device
Generic name
Ezdilate Balloon Dilator (fw) 18-19-20
Manufacturer
Gyrus Acmi, Inc.Model number
BD-400P-2080Lot number
514721
Product problems
- Failure to Deflate
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
The customer reported the ballon stays inflated and it doesn¿t come back out as ideal as it should during a diagnostic Endoscopic submucosal dissection procedure involving an Olympus Ezdilate Balloon Dilator. There was no delay or patient injury reported.
Additional Manufacturer Narrative
This MDR was submitted during the system outage from July 22, 2026, to July 27, 2026, which may result in a delay of receipt of all of the acknowledgements. The investigation is ongoing. A supplemental report will be submitted when the investigation is completed or if additional information becomes available.