MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. EVA, COMBINED MACHINE INCLUDING LASER (SMA CONNECTOR); PHACOEMULSIFICATION/VITRECTOMY SYSTEM

Catalog Number 8000.COM3

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/27/2023

Event Type  malfunction  

Manufacturer Narrative

The complaint is under investigation.In case of a product return, the device will be investigated, otherwise we will review the device history record, and/or any log files if available, or try to replicate the problem on similar product.

Event Description

We have been informed that during surgery, the surgeon was unable to lower the eye pressure, even when the irrigation setting was turned down.The surgeon felt that the eye pressure was from 40 to 50mmhg, while the irrigation setting was 15mmhg from the start.The higher eye pressure remained even after irrigation setting was changed to 2mmhg, which was shown on the screen.Although irrigation was stopped and the eye pressure was reduced by pressing eye directly, the eye pressure was increasing after irrigation re-started in 2mmhg.The surgery was continued and finished with this condition.No report that actual patient harm occurred or surgery was prolonged greater than 30 min.

Event Description

We have been informed that during surgery, the surgeon was unable to lower the eye pressure, even when the irrigation setting was turned down.The surgeon felt that the eye pressure was from 40 to 50mmhg, while the irrigation setting was 15mmhg from the start.The higher eye pressure remained even after irrigation setting was changed to 2mmhg, which was shown on the screen.Although irrigation was stopped and the eye pressure was reduced by pressing eye directly, the eye pressure was increasing after irrigation re-started in 2mmhg.The surgery was continued and finished with this condition.No report that actual patient harm occurred or surgery was prolonged > 30 min.

Manufacturer Narrative

In regard to this complaint, logfiles were provided for review.Review of the logfiles did not show any issues in the unit, except for two pump-related error messages not related to this complaint.It was recommended to monitor the unit.It was reported that the vgpc pressure was according to specifications when measured on (b)(6).Please note that no new complaints regarding this issue on this eva have been logged since the incident was reported.Therefore, based on the available information, it was determined that the reported complaint most likely is not attributable to the unit itself.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 (eva-irrigation not off).Since 2020 more than 850.000 surgeries have been performed with the eva surgical systems installed.

• Brand Name: EVA, COMBINED MACHINE INCLUDING LASER (SMA CONNECTOR)
• 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: petra holland ; scheijdelveweg 2; zuidland, 3214 -VN ; NL 3214 VN
• MDR Report Key: 16529003
• MDR Text Key: 311245630
• Report Number: 1222074-2023-00022
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/08/2023

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 Number: 8000.COM3
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/13/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1