inforMED
MalfunctionFSO

OPMI PICO

Received Dec 19, 2025 · Event occurred Dec 2, 2025

Report 9615010-2025-00024 · MDR key 23853396

Device

Generic name

Microscope, Surgical, General & Plastic Surgery

Model number

PICO

Catalog number

000000-1095-102

Product problems

  • Device Fell
  • Device Fell

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

ON DECEMBER 2, 2025, IT WAS REPORTED THAT PRIOR TO THE START OF A ROOT CANAL PROCEDURE, THE OPMI PICO MICROSCOPE BECAME DETACHED FROM ITS WALL MOUNT. THE MICROSCOPE IS CURRENTLY INOPERABLE. IT WAS CONFIRMED BY THE CUSTOMER THAT THERE WAS NO INJURY TO A PATIENT, USER OR THIRD PARTY DUE TO THE REPORTED EVENT.