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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.COM02
Device Problem Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/30/2021
Event Type  malfunction  
Manufacturer Narrative
The complaint is under investigation.
 
Event Description
It was reported that at the start of a vitrectomy procedure, the cutter did not perform as intended.Unable to solve the issue a second eva was used in order to continue with the procedure.Due to the reported event surgery was prolonged > 30 minutes.No harm to the patient occurred.
 
Manufacturer Narrative
With regard to this event, an eva vitrectomy module was returned for investigation.Investigation of the returned module revealed that one of the cutter valves failed and was stuck in a closed position.Though the eva system will pass the priming phase, the cutter will not be activated because the valve is stuck in the closed position.Also a historical review of the complaint database indicated that no similar complaints have been logged on the eva surgical system subject to this reported event.Based on the information available, it was determined that this event occurred due to a random component failure of a valve inside the vitrectomy module.The risk identified is included in the risk management documentation.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.All similar incidents related to the eva surgical system are included in the analysis.Since 2018 more than 750.000 surgeries have been performed with the eva surgical systems installed.It should be noted that not all failure modes identified as vi-valve-sticky result in prolonged surgery.
 
Event Description
It was reported that at the start of a vitrectomy procedure, the cutter did not perform as intended.Unable to solve the issue a second eva was used in order to continue with the procedure.Due to the reported event surgery was prolonged > 30 minutes.No harm to the patient occurred.
 
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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
zuidland, 3214 VN
NL  3214 VN
Manufacturer (Section G)
D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.
scheijdelveweg 2
zuidland, 3214 VN
NL   3214 VN
Manufacturer Contact
danielle sleegers
scheijdelveweg 2
zuidland, 3214 -VN
NL   3214 VN
MDR Report Key12982701
MDR Text Key282114884
Report Number1222074-2021-00100
Device Sequence Number1
Product Code HQC
Combination Product (y/n)N
Reporter Country CodeSP
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 01/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2021
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
Was Device Evaluated by Manufacturer? Yes
Type of Device Usage Reuse
Patient Sequence Number1
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