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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, COMBINED MACHINE INCLUDING LASER (DORC CONNECTOR); PHACOEMULSIFICATION/VITRECTOMY SYSTEM
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D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. EVA, COMBINED MACHINE INCLUDING LASER (DORC CONNECTOR); PHACOEMULSIFICATION/VITRECTOMY SYSTEM Back to Search Results
Catalog Number 8000.COM02
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problem Insufficient Information (4580)
Event Date 12/19/2023
Event Type  malfunction  
Manufacturer Narrative
The complaint is under investigation.In case of a product return, the device will be investigated, otherwise we will review the device history record, and/or any log files if available, or try to replicate the problem on similar product.As investigations on the actual product or representative sample of a batch may alter the device, we request to inform us within 7 days after submission of this report, in case the investigations that alter the device should be halted until approval of the nca, as per article 89 of eu-mdr.
 
Event Description
After lasering, the eva went into error mode without a message on the screen.The system increased the irrigation/aspiration up to 150 and kept repeating this continuously.Both the screen and the foot pedal could no longer be used.They didn't function anymore.After turning the system off completely it kept repeating '150'.When pulling out the plug this stopped.Then restarted the system and it was good again.(issue date 16/12).No information is available on whether there was impact on patient or delay of surgery for >30 minutes.This has been requested.
 
Manufacturer Narrative
With regard to this event logfiles were provided.Review of the logfiles reveal two times the occurrence of an error code indicating the pedal is not in rest position.It could be that the user pressed the pedal unintended.This could have led to the issues experienced.For a subsequent event with the same eva, there was an issue with the procedure settings.For that event the flashcard has been replaced.Therefor, this event might also be related to the flashcard.
 
Event Description
After lasering, the eva went into error mode without a message on the screen.The system increased the irrigation/aspiration up to 150 and kept repeating this continuously.Both the screen and the foot pedal could no longer be used.They didn't function anymore.After turning the system off completely it kept repeating '150'.When pulling out the plug this stopped.Then restarted the system and it was good again.(issue date 16/12).No information is available on whether there was impact on patient or delay of surgery for >30 minutes.This has been requested.
 
Event Description
After lasering, the eva went into error mode without a message on the screen.The system increased the irrigation/aspiration up to 150 and kept repeating this continuously.Both the screen and the foot pedal could no longer be used.They didn't function anymore.After turning the system off completely it kept repeating '150'.When pulling out the plug this stopped.Then restarted the system and it was good again.(issue date 16/12).No information is available on whether there was impact on patient or delay of surgery for >30 minutes.Dorc has made several attempts to obtain further information, however no additional information was provided.
 
Manufacturer Narrative
In regard to this complaint, logfiles and pictures were provided for review.Based on review of the available information, it was not possible to determine the root cause of the reported complaint.The issue could be attributable either to a use error with the pedal, to a faulty flash card or to a problem when copying settings from the usb key.It cannot be confirmed conclusively from the information available.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.
 
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Brand Name
EVA, COMBINED MACHINE INCLUDING LASER (DORC CONNECTOR)
Type of Device
PHACOEMULSIFICATION/VITRECTOMY SYSTEM
Manufacturer (Section D)
D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.
scheijdelveweg 2
zuidland, 3214 VN
NL  3214 VN
Manufacturer (Section G)
D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.
scheijdelveweg 2
zuidland, 3214 VN
NL   3214 VN
Manufacturer Contact
petra holland
scheijdelveweg 2
zuidland, 3214 -VN
NL   3214 VN
MDR Report Key16051503
MDR Text Key307898457
Report Number1222074-2022-00093
Device Sequence Number1
Product Code HQC
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 04/13/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8000.COM02
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/27/2022
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received02/21/2023
04/13/2023
Was Device Evaluated by Manufacturer? Yes
Type of Device Usage Reuse
Patient Sequence Number1
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