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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 Failure to Prime (1492)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/24/2023
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
We have been informed that during the priming sequence an error npum 61 was displayed.The priming stopped and could not be finished.Repriming did not resolve the issue.Another pack was opened and that priming also failed.The machine was restarted and another pack was used, the priming again failed.The patient was under anesthesia, after 2 hours the patient was taken out of anesthesia because the problem could not be fixed.Unable to solve the issue, it was decided to abort the surgery.No report that actual patient harm occurred.
 
Event Description
We have been informed that during the priming sequence an error npum 61 was displayed.The priming stopped and could not be finished.Repriming did not resolve the issue.Another pack was opened and that priming also failed.The machine was restarted and another pack was used, the priming again failed.The patient was under anesthesia, after 2 hours the patient was taken out of anesthesia because the problem could not be fixed.Unable to solve the issue, it was decided to abort the surgery.No report that actual patient harm occurred.
 
Manufacturer Narrative
In regard to this complaint, a pump module was provided for investigation.Investigation of the returned pump module revealed a defective pneumatic valve inside the module.Due to the defective valve, the module could not pass priming and the eva surgical system was triggered to display the reported pum61 error message on the screen.Based on investigation results, it was determined that the reported complaint is attributable to a random component failure of a pneumatic valve inside the pump module.The risk identified is included in the risk management documentation and the product is performing within anticipated rates.As an increased trend was detected a root cause analysis at the supplier has been requested (scar 2023-007).A root cause analysis at the supplier has been requested (scar 2023-007) all similar incidents related to the eva surgical system are included in the analysis (pu-pneu-valve).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 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.
 
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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 Key18038475
MDR Text Key326959661
Report Number1222074-2023-00077
Device Sequence Number1
Product Code HQC
Combination Product (y/n)N
Reporter Country CodeBE
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 12/22/2023
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 Received10/31/2023
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/22/2023
Was Device Evaluated by Manufacturer? Yes
Type of Device Usage Reuse
Patient Sequence Number1
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