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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA EVA; PHACOEMULSIFICATION/VITRECTOMY SYSTEM
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D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA EVA; PHACOEMULSIFICATION/VITRECTOMY SYSTEM Back to Search Results
Model Number 8000.COM02
Device Problem Unstable (1667)
Patient Problem Edema (1820)
Event Type  malfunction  
Manufacturer Narrative
The machine was removed from the facility for investigation.
 
Event Description
Two weeks ago the surgeon noticed that eva was unstable.It was bad in 3 cases and even with restarting the machine it did not solve the problem.It happened during a test of the new phaco-needle and he initially thought that could be the cause, but even with the needle he normally uses it happened.The surgeon did not fill in a complaint form because he did not know the cause.The surgeon stated that during the demo he thought eva was as stable as a centurion, but this machine is even less stable than an infiniti and he is unhappy.He also notices oedema in some patients.That was not the case before.The surgeon stated that he is very skilled and he can work with the machine without causing damage, but he doesn't want the situation to persist, because it is stressful.
 
Event Description
Two weeks ago the surgeon noticed that eva was unstable.It was bad in 3 cases and even with restarting the machine it did not solve the problem.It happened during a test of the new phaco-needle and he initially thought that could be the cause, but even with the needle he normally uses it happened.The surgeon did not fill in a complaint form because he did not know the cause.The surgeon stated that during the demo he thought eva was as stable as a centurion, but this machine is even less stable than an infiniti and he is unhappy.He also notices oedema in some patients.That was not the case before.The surgeon stated that he is very skilled and he can work with the machine without causing damage, but he doesn't want the situation to persist, because it is stressful.
 
Manufacturer Narrative
The device was returned to the manufacturer for investigation.The device was subjected to intensive testing and was found to be operating normally and within the expected parameters.Although extensive testing was applied it was not possible to replicate the phenomena described by the surgeon during testing.In addition, no anomalies in the log files of the eva system were identified by the dorc r&d department.As a result, no failure mode or root cause related to the eva surgical system can be ascribed to this incident.- attachment: [case (b)(4) final report - signed.Pdf].
 
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Brand Name
EVA
Type of Device
PHACOEMULSIFICATION/VITRECTOMY SYSTEM
Manufacturer (Section D)
D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA
scheijdelveqeg 2
zuiland, 3214 VN
NL  3214 VN
MDR Report Key9181611
MDR Text Key197295629
Report Number1222074-2019-00033
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 Received10/11/2019
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
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