OPMI PICO
Received Aug 19, 2021 · Event occurred Jul 6, 2021
Report 9615010-2021-00003 · MDR key 12345882
Device
Generic name
Opmi Pico
Manufacturer
Carl Zeiss Meditec Ag (oberkochen)Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ISSUE WAS CAUSED DUE TO A LOOSE SAFETY SCREW ON THE OPMI. THE SERVICE MANUAL CLEARLY STATES THAT THE SCREW MUST BE TIGHTENED FIRMLY. THE MANUFACTURING, DESIGN, AND LABELING, IS SUFFICIENT TO PREVENT SUCH AN ISSUE. THE CUSTOMER DECLINED A DEVICE REPAIR AND EVALUATION BY THE MANUFACTURER AND CLAIMED TO HAVE REPAIRED THE DEVICE BY THEIR OWN CLINICAL ENGINEERING DEPARTMENT. IT IS NOT KNOWN WHO IS RESPONSIBLE FOR THE LOOSE SCREW. HOWEVER, DUE TO THE FACT THAT THE LAST PREVENTIVE MAINTENANCE BY ZEISS WAS PERFORMED ONE YEAR AGO WITH NO DEVIATION, AND THE CUSTOMER REPAIRED THE DEVICE BY THEIR OWN ENGINEERING DEPARTMENT, THIS ISSUE WAS POSSIBLY CAUSED BY IMPROPER HANDLING/UNAUTHORIZED PERSON TAMPERING WITH THE DEVICE.
Description of Event or Problem
A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT WHILE THE MICROSCOPE WAS MOVED AWAY FROM THE PATIENT, THE HEAD OF THE OPMI PICO FELL OFF AND WAS CAUGHT BY THE USER. THERE IS NO INDICATION OF ANY SERIOUS INCIDENT CAUSED DUE TO THE REPORTED EVENT.