MalfunctionFSO
OPMI PENTERO
Received Feb 5, 2015 · Event occurred Jan 8, 2015
Report 9615010-2015-00001 · MDR key 4494613
Device
Generic name
Microscope, Surgical General & Plastic
Manufacturer
Carl Zeiss Meditec AgModel number
NACatalog number
000000-0480-801
Lot number
NA
Product problems
- Failure to Conduct
- Electrical /Electronic Property Problem
Patient
NA
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE BIOMEDICAL ENGINEER REPORTED THAT DURING A CRANIAL SURGERY THE LIGHT ON THE PENTERO MICROSCOPE WENT OUT AND AN ERROR MESSAGE APPEARED. AFTER TRYING TO SWITCH TO THE MICROSCOPE BACKUP LAMP, THE ERROR MESSAGE "DEFECTIVE LAMP" APPEARED AND THERE WAS STILL NO LIGHT. A CALL TO THE MANUFACTURER'S TECHNICAL SUPPORT CONFIRMED THAT THE LIGHT SOURCE WAS NOT FUNCTIONING. THE DOCTOR DECIDED TO CLOSE INCISION WITHOUT COMPLETING THE SURGICAL PROCEDURE.
Remedial action
- Repair