MalfunctionHLM
LUXOR Q-VUE
Received Jul 16, 2013 · Event occurred May 31, 2013
Report 2028159-2013-01391 · MDR key 3234243
Device
Generic name
Microscope, Operating And Accessories, Ac-powered, Op
Manufacturer
Alcon - Irvine Technology CenterModel number
Q-VUECatalog number
8065752294
Lot number
NA
Product problems
- Device Operational Issue
- Appropriate Device Problem Term/Code Not Available
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
A CUSTOMER REPORTED THAT DURING A PROCEDURE, THEY COULD NOT CONTROL THE FOCUS WITH THE FOOTSWITCH. THE PROCEDURE WAS COMPLETED AFTER EXCHANGING THE MICROSCOPE. THERE WAS NO PATIENT HARM.
Additional Manufacturer Narrative
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).