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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER B.V. EVA, COMBINED MACHINE INCLUDING LASER (DORC CONNECTOR); PHACOEMULSIFICATION/VITRECTOMY SYSTEM
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D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER B.V. EVA, COMBINED MACHINE INCLUDING LASER (DORC CONNECTOR); PHACOEMULSIFICATION/VITRECTOMY SYSTEM Back to Search Results
Catalog Number 8000.COM02
Device Problem Output below Specifications (3004)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/21/2023
Event Type  malfunction  
Event Description
We have been informed that during surgery, the phaco power was very low.They have tried to increase the power, change the cassette, and change the handpiece but the problem still persisted.Another machine was used to continue the surgery.Surgery was prolonged > 30 mins.No report that actual patient harm occurred.
 
Manufacturer Narrative
The complaint is under investigation.No corrective or preventive actions can be implemented until the investigation has been completed.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.
 
Manufacturer Narrative
The issue encountered could not be seen upon review of the logfiles.It was recommended to monitor the situation and replace the phacodiathermy module if it happens again.Sometimes, a reboot of the unit may solve the issue.The complaint could be attributable to the handpiece, however this cannot be confirmed.Unfortunately, the complaint cannot be further investigated nor confirmed conclusively as no product was returned to d.O.R.C for investigation.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.All similar incidents related to the eva surgical system are included in the analysis (pd-defect-).Since 2020 more than 850.000 surgeries have been performed with the eva surgical systems installed.Please note that the failure codes will not always lead to a prolonged/delayed surgery.Please note that while the 2023 incident numbers are up to date, the 2023 installed base figures are from april 25th 2023.As in general the installed base increases, the actual number of devices in the market most likely is slightly higher.
 
Event Description
We have been informed that during surgery, the phaco power was very low.They have tried to increase the power, change the cassette, and change the handpiece but the problem still persisted.Another machine was used to continue the surgery.Surgery was prolonged > 30 mins.No report that actual patient harm occurred.
 
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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 B.V.
scheijdelveweg 2
zuidland, 3214 VN
NL  3214 VN
Manufacturer (Section G)
D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER B.V.
scheijdelveweg 2
zuidland, 3214 VN
NL   3214 VN
Manufacturer Contact
petra holland
scheijdelveweg 2
zuidland, 3214 -VN
NL   3214 VN
MDR Report Key17548255
MDR Text Key321144728
Report Number1222074-2023-00059
Device Sequence Number1
Product Code HQC
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2023
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
Was Device Evaluated by Manufacturer? Yes
Type of Device Usage Reuse
Patient Sequence Number1
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