MalfunctionFSO
OPMI PENTERO
Received Feb 27, 2026 · Event occurred Feb 2, 2026
Report 9615010-2026-00001 · MDR key 24475989
Device
Generic name
Microscope, Surgical, General & Plastic Surgery
Manufacturer
Carl Zeiss Meditec Ag (oberkochen)Model number
PENTEROLot number
N/A
Product problems
- Circuit Failure
- Smoking
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
CUSTOMER IN GERMANY REPORTED THAT THE OPMI PENTERO MICROSCOPE ACTIVATED THE SMOKE DETECTOR AND FIRE ALARM SYSTEM, PROMPTING THE PRESENCE OF THE FIRE DEPARTMENT AND POLICE IN THE OPERATING ROOM. IT WAS CONFIRMED BY THE CUSTOMER THAT THERE WAS NO INJURY TO A PATIENT, USER OR THIRD PARTY DUE TO THE REPORTED EVENT.