OPMI PICO ON S100 FLOOR STAND
Received Feb 6, 2014 · Event occurred Jan 8, 2014
Report 9615010-2014-00006 · MDR key 3894155
Device
Generic name
Microscope, Surgical, General And Pla
Manufacturer
Carl Zeiss Meditec AgModel number
S100 FLOORSTANDCatalog number
000000-1403-542
Lot number
NA
Product problems
- Installation-Related Problem
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE CUSTOMER HEARD A NOISE AND WENT INTO THE PROCEDURE ROOM. THEY FOUND THE LAMP HOUSING (XENON POWER SUPPLY ILLUMINATION UNIT) HAD FALLEN AND WAS HANGING BY THE CABLES FROM THEIR OPMI PICO MICROSCOPE S100 FLOOR STAND. THE CUSTOMER CONFIRMED THAT NO ONE WAS INJURED.
Additional Manufacturer Narrative
THE FIELD SERVICE ENGINEER (FSE) FOUND THAT ALL FOUR BOLTS SECURING THE XENON POWER SUPPLY ILLUMINATION UNIT MOUNTING PLATE TO THE S100 STAND WERE BROKEN. THE MICROSCOPE WAS REPAIRED. SITE CONTACT IS SAME AS INITIAL REPORTER.
Remedial action
- Repair