MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. EVA; PHACOEMULSIFICATION/VITRECTOMY SYSTEM

Catalog Number 8000.COM05

Device Problem Communication or Transmission Problem (2896)

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

Event Date 04/22/2022

Event Type  malfunction  

Manufacturer Narrative

The complaint is under investigation.

Event Description

We have been informed that during vitrectomy procedure, the eva triggered a message regarding the fact that the system was unable to charge the foot switch.The user was unable to resolve the issue.No report of patient/user harm.However, the procedure was prolonged due to this event.

Manufacturer Narrative

The device has not 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, the eva triggered a message during priming indicating that no irrigation was available the user was unable to resolve the issue but the completed the procedure by using a back-up machine.No patient/user harm.However, due to this event the surgery is prolonged with more than 30 minutes.

Manufacturer Narrative

The complaint is under investigation.No corrective or preventive actions can be implemented until the investigation has been completed.The device has been returned for investigation.Please be informed that the investigation is ongoing.

Event Description

We have been informed that during procedure, the eva triggered a message during priming indicating that no irrigation was available the user was unable to resolve the issue but the completed the procedure by using a back-up machine.No patient/user harm.However, due to this event the surgery is prolonged with more than 30 minutes.

Event Description

We have been informed, that during procedure.The eva triggered a message, during priming.Indicating, that no irrigation was available.The user was unable to resolve the issue, but the completed the procedure by using a back-up machine.No patient/user harm.However, due to this event, the surgery is prolonged with more than 30 minutes.

Manufacturer Narrative

The device has not been returned/ accessible for investigation yet.The investigation will be continued, when the device is available for examination.We have received confirmation, that the product will be returned for investigation soon.

Manufacturer Narrative

With regards to this event a rf plate was returned for investigation.Investigation of the returned item determined a defective fuse on the rf plate.Due to the defective fuse, the power source to the main pedal was cut off.This triggered the eva surgical system to generate the error message on the screen.Historical review of the complaint database indicated that no similar complaints have been logged on this eva surgical system subject to this complaint prior to the reported event.Furthermore, no repeat issues were reported after the rf plate was replaced with a new one.Based upon the available information it was concluded that the root cause of this event is related to a random component failure of the rf plate fuse.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.Trend analysis indicates that the product is performing within anticipated rates.Therefore, no remedial or corrective/preventive actions will be undertaken at this moment.As a preventive action to improve the rf-print reliability a design change was implemented in 2017.However, the item subject to this event was manufactured prior to this date.All similar incidents related to the eva surgical system are included in the analysis.Since 2019 more than 850.000 surgeries have been performed with the eva surgical systems installed.

Event Description

We have been informed that during procedure, the eva triggered a message during priming indicating that no irrigation was available the user was unable to resolve the issue but the completed the procedure by using a back-up machine.No patient/user harm.However, due to this event the surgery is prolonged with more than 30 minutes.

• 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 Key: 14336451
• MDR Text Key: 291249641
• Report Number: 1222074-2022-00036
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8000.COM05
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1