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

Catalog Number 8000.COM05

Device Problems Free or Unrestricted Flow (2945); Improper Flow or Infusion (2954)

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

Event Date 03/06/2022

Event Type  malfunction  

Manufacturer Narrative

The complaint is under investigation.

Event Description

It has been reported that during procedure , the machine stopped working and the display gave an warning message indicating that the aspiration sensors and fluidics module were offline.The surgeon was able complete the surgery with a back-up unit.Due to the reported event surgery was prolonged >30 minutes.No actual patient harm occurred.

Event Description

It has been reported that during procedure, the machine stopped working and the display gave an warning message indicating that the aspiration sensors and fluidics module were offline.The surgeon was able complete the surgery with a back-up unit.Due to the reported event surgery was prolonged >30 minutes.No actual patient harm occurred.

Manufacturer Narrative

With regard to this event the eva system was not returned for investigation.However, logfiles were provided for review.Review of the logfiles confirmed the occurrence of the error message indicating that the pump module of the eva surgical system was offline.Investigation of the system by the field service technician did not reveal any anomalies.In addition, no repeat issues have been reported on the eva system involved since the reported event.Based upon the investigation performed the root cause of the reported event remains unclear.Trend analysis indicates that the product is performing within anticipated rates.Therefore, no remedial or corrective/preventive actions will be undertaken at this moment.The user is advised to monitor the situation and contact dorc if the issue reoccurs.In addition, 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: 13869672
• MDR Text Key: 291967893
• Report Number: 1222074-2022-00026
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: TC
• 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: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• 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