inforMED
InjuryFSO

OPMI VARIO

Received Nov 7, 2018 · Event occurred Oct 8, 2018

Report 9615010-2018-00014 · MDR key 8049027

Device

Generic name

Microscope, Surgical, General & Plastic Surgery

Model number

N/A

Catalog number

000000-1026-700

Lot number

N/A

Product problems

  • Misfocusing
  • Use of Device Problem
  • Improper or Incorrect Procedure or Method
  • Misfocusing
  • Use of Device Problem
  • Improper or Incorrect Procedure or Method

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

ACCORDING TO THE MANUFACTURER THE FAILURE OF THE FOCUS FUNCTION OCCURRED DUE TO AN INCORRECT FITTING OF A THIRD PARTY DRAPE TO THE DEVICE. THE DRAPE GOT TANGLED AROUND THE FOCUS KNOB CAUSING IT TO BECOME STUCK. THE USER MANUAL INSTRUCTS THE USER TO ENSURE THE PROPER DRAPING OF THE SYSTEM TO ALLOW PROPER MOVEMENT OF THE MICROSCOPE. (B)(4).

Description of Event or Problem

A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE FOCUS FUNCTION OF THE OPMI VARIO MICROSCOPE STOPPED WORKING AFTER 1 HOUR AND 30 MINUTES INTO A SURGERY. THE SYSTEM DISPLAYED ERROR #12, RELATED TO THE ZOOM END POSITION. THE HCP DECIDED TO ABORT THE PROCEDURE AND RESCHEDULED IT FOR A LATER DATE. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.