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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. EVA; PHACOEMULSIFICATION/VITRECTOMY SYSTEM
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D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. EVA; PHACOEMULSIFICATION/VITRECTOMY SYSTEM Back to Search Results
Catalog Number 8000.COM05
Device Problems Decrease in Pressure (1490); Device Displays Incorrect Message (2591)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/22/2021
Event Type  malfunction  
Manufacturer Narrative
The product is not available for investigation.The complaint will be investigated based upon the information from the logfiles and device history records.
 
Event Description
We were informed that during a combined procedure, in step core vitrectomy, error message "pum72" was displayed on the screen.After confirming the notification on the touchscreen to start recalibration of the failing sensor, the eye became very soft.No surgical delay or actual patient harm occurred.
 
Event Description
We were informed that during a combined procedure, in step core vitrectomy, error message "pum72" was displayed on the screen.After confirming the notification on the touchscreen to start recalibration of the failing sensor, the eye became very soft.No report of a delay or that actual patient harm occurred.
 
Manufacturer Narrative
With regard to this complaint the eva surgical system was inspected on location and log files were provided for review.Review of the log files confirmed the occurrence of the pum72 error message indicating that "there is a difference detected between the aspiration pressure sensor and the backup sensor.For safety reason, pump is in pause mode." which was followed by the calibration of the sensors.However, the log files could not reveal any anomalies related to a decrease in irrigation which could result in the reported soft eye.Inspection of the eva surgical system on location did not reveal any anomalies and confirmed the eva system functioned within specification.Review of the complaint database indicated that no similar complaints have been logged on the eva surgical system subject to this complaint until today.Therefore, the investigation findings did not lead to a clear conclusion regarding the cause of the reported adverse event.The risk identified is included in the risk management documentation.Trend analysis indicates 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.No corrective or preventive actions will be implemented as a result of this incident.
 
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Brand Name
EVA
Type of Device
PHACOEMULSIFICATION/VITRECTOMY SYSTEM
Manufacturer (Section D)
D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.
scheijdelveweg 2
zuiland, 3214V N
NL  3214VN
MDR Report Key11701290
MDR Text Key249505104
Report Number1222074-2021-00028
Device Sequence Number1
Product Code HQC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 05/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number8000.COM05
Patient Sequence Number1
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