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

Catalog Number 8000.COM02

Device Problem Communication or Transmission Problem (2896)

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

Event Date 05/06/2022

Event Type  malfunction  

Manufacturer Narrative

The complaint is under investigation.

Event Description

We have been informed that during procedure, the eva triggered a message regarding indicating that rf receiver was unable to charge the footswitch.The user was unable to resolve the issue.Due to the reported event surgery was prolonged > 30 minutes.No report that actual patient harm 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 triggered a message regarding indicating that rf receiver was unable to charge the footswitch.The user was unable to resolve the issue.Due to the reported event surgery was prolonged > 30 minutes.No report that actual patient harm occurred.

Manufacturer Narrative

With regard to this complaint an rf receiver for the eva foot pedal was returned for investigation.Investigation of the returned rf receiver revealed that, due to a defective fuse, the rf receiver was unable to charge the foot pedal.The inability to charge the foot pedal was detected by the eva surgical system which triggered the system to present the reported message on the screen.Review of the complaint database indicated that no similar complaints have been logged on the eva surgical system subject to this complaint until today.Based on the investigation performed, it was determined that the reported event is attributable to component failure of the fuse of the rf receiver.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.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.Please note this defect will not always result in delayed surgery.

Event Description

We have been informed that during procedure, the eva triggered a message regarding indicating that rf receiver was unable to charge the footswitch.The user was unable to resolve the issue.Due to the reported event surgery was prolonged > 30 minutes.No report that actual patient harm occurred.

• 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: 14572755
• MDR Text Key: 301348933
• Report Number: 1222074-2022-00048
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: SA
• 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: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8000.COM02
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1