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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; PHACO-EMULSIFICATION/VITRECTOMY SYSTEM
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D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. EVA; PHACO-EMULSIFICATION/VITRECTOMY SYSTEM Back to Search Results
Catalog Number 8000.COM05
Device Problem Increase in Pressure (1491)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
A report was received that during a vitrectomy procedure after lasering when changing to perform an air liquid exchange the pressure increased completely independently in 5 mmhg steps to 150 mmhg.The nurse lowed the pressure manually, after which the pressure increased again, the nurses lowed it manually, it increased again.The surgeon disconnected the infusion line to protect the eye.Changing the program via the memory button was successful but the uncontrolled pressure increase remained.They finished the program and started to prime another procedure.Priming started and ended and started again after which they removed the plug from the socket.After that they started the unit once more, primed, started the procedure and they completed the procedure with this unit without any problems.No patient harm occurred.
 
Manufacturer Narrative
With regard to this event, a foot pedal and logfiles were returned for investigation.Visual inspection of the pedal showed damage on the outside of the pedal.Functional testing of the main pedal did not reveal any anomalies.Despite the damage on the outside of the pedal, it functioned in compliance with release specifications.Therefore, the reported event cannot be attributed to the pedal that was returned for investigation.Review of the logfiles revealed that, due to a software bug, the situation can occur that the "irrigation up" cannot be deactivated by releasing the "irrigation up" button on the foot pedal.This situation occurs when the "irrigation up" button is pressed while simultaneously switching to another procedure step where the buttons have different functions.Then the "irrigation up" function will stay activated and the irrigation will increase until the set pressure is reached.Since the irrigation pressure is indicated on the screen and the irrigation pressure will not exceed the set maximum pressure, the likelihood that such an event will cause actual harm is considered remote.The risk identified is included in the risk management documentation.Trend analysis indicates that the product is performing within anticipated rates.Complaints will be closely monitored to identify any significant adverse trends.It should be noted that the software bug was resolved with an update of the software.Complaints will be closely monitored to identify any significant adverse trends.
 
Event Description
The surgeon was performing a hybrid vitrectomy.After lasering he wanted to perform an air liquid exchange.Then the pressure increased completely independently in 5 mmhg steps to 150 mmhg.The nurse lowered the pressure manually, it increased again, the nurses lowered it manually, it increased again and so on.The surgeon disconnected the infusion line to protect the eye.Then the nurses tried via the memory button to exchange the program to, for example, 23ga vitrectomy.That worked but the uncontrolled pressure increase remained.Then they finished the program and started to prime another procedure.Priming started and ended and started again.Then they removed the plug from the socket.After that they started the unit once more, primed, started the procedure and they completed the procedure with this unit without any problems.
 
Manufacturer Narrative
The incident is still under investigation.No corrective or preventive actions can be implemented until the investigation has been completed.Product evaluation is required to reach our final conclusion.
 
Event Description
A report was received that during a vitrectomy procedure after lasering when changing to perform an air liquid exchange the pressure increased completely independently in 5 mmhg steps to 150 mmhg.The nurse lowed the pressure manually, after which the pressure increased again, the nurses lowed it manually, it increased again.The surgeon disconnected the infusion line to protect the eye.Changing the program via the memory button was successful but the uncontrolled pressure increase remained.They finished the program and started to prime another procedure.Priming started and ended and started again after which they removed the plug from the socket.After that they started the unit once more, primed, started the procedure and they completed the procedure with this unit without any problems.No patient harm occurred.
 
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Brand Name
EVA
Type of Device
PHACO-EMULSIFICATION/VITRECTOMY SYSTEM
Manufacturer (Section D)
D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.
scheijdelveweg 2
zuidland,
NL 
MDR Report Key11028912
MDR Text Key223817595
Report Number1222074-2020-00087
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,Followup
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 No Information
Device Catalogue Number8000.COM05
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/17/2020
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received02/01/2021
03/15/2021
Patient Sequence Number1
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