Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. EVA; PHACO-EMULSIFICATION/VITRECTOMY SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. EVA; PHACO-EMULSIFICATION/VITRECTOMY SYSTEM Back to Search Results
Model Number 8000.COM02
Device Problems Device Emits Odor (1425); Failure to Power Up (1476); Optical Problem (3001)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The unit is currently being investigated to determine the cause of the incident.
 
Event Description
When the machine was started up it didn't light up.The nurse checked on the back that the power supply was in order and tried again.The machine started but after a little while it started to smell burnt.The next day the machine would not start at all.The failure was noted prior to use.No harm occurred.
 
Event Description
When the machine was started up it didn't light up.The nurse checked on the back that the power supply was in order and tried again.The machine started but after a little while it started to smell burnt.The next day the machine would not start at all.The failure was noted prior to use.No harm occurred.
 
Manufacturer Narrative
With regard to this complaint, a mainboard was received for investigation.Visual inspection showed no deviations.However, a burn smell of the components lingered.With the functional inspection problems with start-up were confirmed and the unit did not start.After internal inspection, burn marks were identified on the pcb.Device history review revealed no anomalies during product release or during preventive maintenance.Based upon the information available the cause of the event is considered a random component failure of the mainboard pcb.Review of the complaint database indicated that this event is a single occurrence.Trend analysis indicate that the product is performing within anticipated rates.Therefore, no remedial or corrective/preventive actions will be undertaken at this moment.Complaints will be closely monitored to identify any significant adverse trends.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EVA
Type of Device
PHACO-EMULSIFICATION/VITRECTOMY SYSTEM
Manufacturer (Section D)
D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.
scheijdelveweg 2
zuidland,
NL 
MDR Report Key10793926
MDR Text Key216766824
Report Number1222074-2020-00077
Device Sequence Number1
Product Code HQC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number8000.COM02
Patient Sequence Number1
-
-