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

Catalog Number 8000.COM03

Device Problems Decrease in Pressure (1490); Increase in Pressure (1491)

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

Event Date 04/05/2021

Event Type  malfunction  

Manufacturer Narrative

The device involved in the incident will be returned for investigation.

Event Description

It was reported that during a vitrectomy procedure it was not possible to restart the system after an error message was displayed on the monitor.Due to this event surgery is delayed.No actual patient harm occurred.

Manufacturer Narrative

The device involved in the incident is returned for investigation.No corrective or preventive actions can be implemented until the investigation has been completed.The device is returned for investigation.Investigation is ongoing.

Event Description

It was reported that during a vitrectomy procedure it was not possible to restart the system after an error message was displayed on the monitor.Due to this event surgery is delayed.No actual patient harm occurred.

Manufacturer Narrative

With regard to the reported event, an eva pump module was returned for investigation.Investigation of the returned pump module revealed broken dampers inside the module.The broken vibration dampers will cause the rotor to be in an incorrect position.The incorrect rotor position will be detected by the eva surgical system and trigger the system to present the reported error 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.Also a dhr review did not reveal any anomalies.Based on the investigation results, it was determined that the reported event is attributable to a component failure of the dampers inside the pump module.As a preventive action a design change to improve the reliability of the damper was implemented in 2016.However, the pump module subject to this reported event was manufactured prior to this date.

Event Description

It was reported that during a vitrectomy procedure it was not possible to restart the system after an error message was displayed on the monitor.Due to this event surgery is delayed.No actual patient harm occurred.

Manufacturer Narrative

The device involved in the incident is returned for investigation.No corrective or preventive actions can be implemented until the investigation has been completed.The device is returned for investigation.Investigation is ongoing.

Event Description

It was reported that during a vitrectomy procedure it was not possible to restart the system after an error message was displayed on the monitor.Due to this event surgery is delayed.No 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; zuiland, 3214V N; NL 3214VN
• MDR Report Key: 11786607
• MDR Text Key: 252204083
• Report Number: 1222074-2021-00033
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/08/2021

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: No Information
• Device Catalogue Number: 8000.COM03
• Initial Date Manufacturer Received: 05/06/2021
• Initial Date FDA Received: 05/06/2021
• Supplement Dates Manufacturer Received: 05/06/2021; 05/06/2021; 05/06/2021
• Supplement Dates FDA Received: 06/17/2021; 07/28/2021; 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1