FDAAdverse Event

[AIZU OLYMPUS CO., LTD.] EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE — Malfunction

Jan 28, 2026

Date Received: 20260128Captured: 2026-02-24AIZU OLYMPUS CO., LTD.Device: GASTROINTESTINAL VIDEOSCOPEProduct Code: FDS

Device: GASTROINTESTINAL VIDEOSCOPE | Patient outcome(s): | [Description of Event or Problem] IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE HAD FOREIGN OBJECTS IN THE NOZZLE. THERE WAS NO PATIENT INVOLVEMENT. | [Additional Manufacturer Narrative] THE DEVICE W...

•Agency: FDA
•Type: adverse_event
•Source available

Event Description

IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE HAD FOREIGN OBJECTS IN THE NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.

Report Type:['Initial submission', 'Followup']

Source Type:['Company representation']

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