MalfunctionHLM
ACCURUS 400 VS
Received Jun 8, 2012 · Event occurred Apr 26, 2012
Report 2028159-2012-00838 · MDR key 2617337
Device
Generic name
Phacofragmentation System
Manufacturer
Alcon - Irvine Technology CenterModel number
ACCURUSCatalog number
8065740238
Lot number
NA
Product problems
- Aspiration Issue
- Device Operational Issue
Patient
Not reported
- No Consequences Or Impact To Patient
- No Code Available
Narrative
Description of Event or Problem
A CUSTOMER REPORTED THAT THE EQUIPMENT DISPLAYED DEFICIENT ASPIRATION AND FLUID/GAS EXCHANGE FAILURE DURING A VITRECTOMY PROCEDURE. AFTER A DELAY OF MORE THAN 15 MINUTES, THE CASE WAS ABLE TO BE COMPLETED WITH THE SAME EQUIPMENT. ADD'L INFO HAS BEEN REQUESTED.
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 ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).