inforMED
MalfunctionFSO

OPMI PICO ON S100 FLOORSTAND

Received Dec 10, 2020 · Event occurred Nov 12, 2020

Report 9615010-2020-00009 · MDR key 10985322

Device

Generic name

Opmi Pico

Model number

PICO

Lot number

N/A

Product problems

  • Misassembly During Maintenance/Repair
  • Misassembly During Maintenance/Repair

Patient

Not reported

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

Narrative

Description of Event or Problem

A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT AT THE BEGINNING OF A ROOT CANAL CASE, WHEN THE HCP WAS MOVING THE MICROSCOPE TOWARDS THE PATIENT, THE OPMI HEAD FELL OFF OF THE STAND. THE HCP WAS SUPPORTING THE OPMI HEAD WITH BOTH HANDS, WHEN THE INCIDENT OCCURRED, AND THAT IT WAS OFF TO THE SIDE OF THE PATIENT. THE HCP WAS ABLE TO MOUNT THE OPMI HEAD BACK ONTO THE STAND, AND COMPLETED THE PROCEDURE SUCCESSFULLY WITH MINOR DELAY. THERE WAS NO INJURY REPORTED TO THE PATIENT, OR THE DOCTOR.