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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; PHACOEMULSIFICATION/VITRECTOMY SYSTEM
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D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. EVA; PHACOEMULSIFICATION/VITRECTOMY SYSTEM Back to Search Results
Catalog Number 8000.COM01
Device Problems Defective Component (2292); Failure to Cut (2587); Activation Problem (4042)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/23/2021
Event Type  malfunction  
Manufacturer Narrative
The complaint is under investigation.
 
Event Description
We were informed that during procedure the surgeon could utilize all functions (irrigation on/off; diathermy, etc) except the cutter with main pedal.Therefore, it was decided to abort the procedure and reschedule the surgery for another date.
 
Manufacturer Narrative
With regard to this reported, only a complaint form was received.Unfortunately no product or logfiles were available for investigation.Two warning messages were prompted by eva as included in the complaint form: "the foot pedal is not in a horizontal position.Please ensure the pedal is in horizontal position" and "an undefined horizontal position of the pedal is detected.Please make sure the turning knob is centered".These warning messages are triggered by the eva surgical system when the pedal is not in horizontal position (e.G.By picking it up) and the pedal's turning knob is not centered.Review of the complaint database indicated that no similar events were reported on this eva surgical system.In case malfunction of the pedal can be ruled out as potential cause of the event, the reported event is most likely related to an unintended use error.Recently, we were informed that the related pedal will be returned for investigation, therefore the investigation into the cause of the event will continue after the product has been received.No corrective or preventive actions can be implemented until the investigation has been completed.The device has not yet been returned for investigation yet.Reminders have been sent and the a confirmation has been recieved that the product will be returned for investigation.The investigation will be completed after the device has been received.
 
Event Description
We were informed that during procedure the surgeon could utilize all functions (irrigation on/off; diathermy, etc) except the cutter with main pedal.Therefore, it was decided to abort the procedure and reschedule the surgery for another date.
 
Manufacturer Narrative
With regard to this event, an eva foot pedal was returned for investigation.During visual inspection it was observed that 2 rubbers of the rocker switches were torn, in addition, a small tear in the bottom of the housing was observed.Functional investigation of the pedal revealed a damaged potentiometer which caused the position value to be off-center when the main pedal is in the neutral position.This resulted in an reported error messages on the screen which indicate an issue with the horizonal pedal position.No logfiles were available, therefore no logfile review could be performed.Historical review of the complaint database indicated that no similar complaints have been logged on this eva surgical system.Based upon the available information, the reported event is considered to be attributable to a random component failure.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.The risk identified is included in the risk management documentation.No corrective or preventive actions will be implemented as a result of this incident.
 
Event Description
We were informed that during procedure the surgeon could utilize all functions (irrigation on/off; diathermy, etc) except the cutter with main pedal.Therefore, it was decided to abort the procedure and reschedule the surgery for another date.
 
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Brand Name
EVA
Type of Device
PHACOEMULSIFICATION/VITRECTOMY SYSTEM
Manufacturer (Section D)
D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.
scheijdelveweg 2
zuiland, 3214V N
NL  3214VN
MDR Report Key11604194
MDR Text Key246315840
Report Number1222074-2021-00014
Device Sequence Number1
Product Code HQC
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup,Followup
Report Date 06/16/2021
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.COM01
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/01/2021
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received05/05/2021
06/16/2021
Patient Sequence Number1
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