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

Catalog Number 8000.COM07

Device Problem No Display/Image (1183)

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

Event Date 07/07/2022

Event Type  malfunction  

Manufacturer Narrative

The complaint is under investigation.

Event Description

We have been informed that during procedure, the eva screen froze when switching steps.The user was able to resolve the issue by rebooting the eva.Due to the reported event surgery was prolonged > 30 minutes.No harm to the patient occurred.

Event Description

We have been informed, that during procedure.The eva screen froze, when switching steps.The user was able to resolve the issue, by rebooting the eva.Due to the reported event, surgery was prolonged, 30 minutes.No harm to the patient occurred.

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 screen froze when switching steps.The user was able to resolve the issue by rebooting the eva.Due to the reported event surgery was prolonged > 30 minutes.No harm to the patient occurred.

Manufacturer Narrative

With regard to this event logfiles were provided for review.Review of the log files of the eva system did not reveal any signals of a crash or a problem reported from the eva system.Based on the description of the event, that the touch screen did not work and that is was solved by re-booting the system, it is most likely caused by the operating system.It could be that the operating system was running out of resources or that the memory on the cfast card was not sufficient at the time of the event.However, this cannot be defined conclusively.The user was advised to monitor the situation and contact dorc if the issue reoccurs.Review of the complaint database indicated that no similar issues have been logged on this eva surgical system since the event occurred.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 2019 more than 850.000 surgeries have been performed with the eva surgical systems installed.Please note that not all occurrences of the reported error message will lead to a prolonged surgery.

• 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: 15155552
• MDR Text Key: 298500176
• Report Number: 1222074-2022-00054
• 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,Followup
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8000.COM07
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1