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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
Catalog Number 8000.COM02
Device Problem Suction Failure (4039)
Patient Problem Collapse (2416)
Event Type  Injury  
Manufacturer Narrative
Investigation will be initiated as soon as possible.The log files from the equipment have been requested for investigation.
 
Event Description
Chief surgeon had just finished a 23g combined surgery.During sculpting he had no aspiration.He switched to quadrant removal and he got the aspiration back.Then he went to the vitrectomy part and everything went well until he did the fluid air exchange.There was no air.He switched back and fourth from fluid to air but no response.The eye collapsed, but not totally.He finally injected the air into the eye manually with a syringe.
 
Event Description
Chief surgeon had just finished a 23g combined surgery.During sculpting he had no aspiration.He switched to quadrant removal and he got the aspiration back.Then he went to the vitrectomy part and everything went well until he did the fluid air exchange.There was no air.He switched back and fourth from fluid to air but no response.The eye collapsed, but not totally.He finally injected the air into the eye manually with a syringe.
 
Manufacturer Narrative
With regard to this complaint, the eva system with alleged problems was requested by d.O.R.C.For investigation.Only the log files were provided by the customer.An analysis of the log files did not reveal any error codes relating to issues reported.In fact, the log files did not show any abnormalities in the functioning of the machine.Since no product was returned for investigation, it is not possible to determine a root cause for the reported event.Right after the time of the event a general check of the tubing, connections and valves was performed by our regional technical application specialist.No further issues of this sort were reported afterwards and the eva system is fully operational.The performance of this unit will be further monitored.(b)(4).
 
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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 Key9575131
MDR Text Key174709598
Report Number1222074-2019-00051
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 Received01/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number8000.COM02
Patient Sequence Number1
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