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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.COM05
Device Problem Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/18/2022
Event Type  malfunction  
Event Description
We have been informed that during procedure, while performing core vitrectomy, the machine gave an error message.The user was not able to solve the issue and it was decided to abort the surgery.No report that actual patient harm occurred.
 
Manufacturer Narrative
The complaint is under investigation.
 
Manufacturer Narrative
The device has not yet been returned/accessible for investigation yet.The investigation will be continued when the device is available for examination.
 
Event Description
We have been informed that during procedure, while performing core vitrectomy, the machine gave an error message.The user was not able to solve the issue and it was decided to abort the surgery.No report that actual patient harm occurred.
 
Manufacturer Narrative
The device has not yet been returned/ accessible for investigation yet.The investigation will be continued when the device is available for examination.
 
Event Description
We have been informed that during procedure, while performing core vitrectomy, the machine gave an error message.The user was not able to solve the issue and it was decided to abort the surgery.No report that actual patient harm occurred.
 
Event Description
We have been informed that during procedure, while performing core vitrectomy, the machine gave an error message.The user was not able to solve the issue and it was decided to abort the surgery.No report that actual patient harm occurred.
 
Manufacturer Narrative
With regards to this event, a vitrectomy module was received for investigation.Investigation of the returned module revealed that a particle was stuck in one of the valves of the vitrectomy module preventing the valve from functioning correctly.Based upon the nature of the particle it was determined that the particle originated from an aspiration tubing of a vitrectomy cutter.The vitrectomy module itself was released according to the release specification in q2 2018 and no issues were reported until the reported event.The root cause of the presence of the particle identified was related to the assembly of one of the vitrectomes used.Corrective actions have been implemented to prevent similar events from occurring, where trend analysis indicates that the eva surgical system is performing within anticipated rates.Therefore, no remedial actions or corrective/preventive actions will be undertaken at this moment.Complaints will be monitored to identify any significant adverse trends.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.
 
Manufacturer Narrative
The complaint is under investigation.No corrective or preventive actions can be implemented until the investigation has been completed.The device has not yet been returned/ accessible for investigation yet.The investigation will be continued when the device is available for examination.
 
Event Description
We have been informed that during procedure, while performing core vitrectomy, the machine gave an error message.The user was not able to solve the issue and it was decided to abort the surgery.No report that actual patient harm 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 Key13289530
MDR Text Key287267477
Report Number1222074-2022-00003
Device Sequence Number1
Product Code HQC
Combination Product (y/n)N
Reporter Country CodeIR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/24/2022
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 Health Professional
Device Catalogue Number8000.COM05
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/19/2022
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
Not provided
Supplement Dates FDA Received03/01/2022
03/01/2022
04/12/2022
05/24/2022
Was Device Evaluated by Manufacturer? Yes
Type of Device Usage Reuse
Patient Sequence Number1
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