MalfunctionFSO
OPMI PICO
Received Jul 6, 2026 · Event occurred Jun 8, 2026
Report 9615010-2026-00009 · MDR key 25725637
Device
Generic name
Microscope, Surgical, General & Plastic Surgery
Manufacturer
Carl Zeiss Meditec Ag (oberkochen)Model number
PICOCatalog number
000000-1095-102
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
DURING A SURGICAL PROCEDURE USING AN OPMI PICO, THE LIGHT SUDDENLY WENT OUT, ACCOMPANIED BY A POPPING SOUND AND A BURNING SMELL. AT THAT TIME, THE PATIENT HAD ALREADY BEEN PREPARED AND ANESTHETIZED. DUE TO THE INCIDENT, THE PROCEDURE WAS RESCHEDULED. THERE IS NO INFORMATION ABOUT ANY VISIBLE FLAME, FIRE, SPARK OR ANY THERMAL DAMAGE NOTICED ON THE DEVICE.
Additional Manufacturer Narrative
H6: MEDICAL DEVICE PROBLEM CODE PREFERRED TERM: BURNING SMELL FROM DEVICE.