MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. EVA, COMBINED MACHINE NCBF INCLUDING LASER (DORC CONNECTOR); 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 01/12/2023

Event Type  malfunction  

Manufacturer Narrative

The complaint is under investigation.In case of a product return, the device will be investigated, otherwise we will review the device history record, and/or any log files if available, or try to replicate the problem on similar product.

Event Description

We have been informed during procedure the pedal stopped working.No actual patient harm occured.Surgery was prolonged > 30 minutes.

Manufacturer Narrative

In regard to this complaint, logfiles and pictures were provided for review.Review of the logfiles revealed multiple fop65541 error messages, indicating an undefined horizontal position of the main pedal.It was advised to set the turning knob to the middle to see if it solves the problem.Based on review of the available information, it was determined that the reported complaint most likely is attributable to a sensor issue.However, it cannot be confirmed conclusively as the pedal was not returned to d.O.R.C for investigation.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 (all failure modes including error code fop65541).Since 2020 more than 850.000 surgeries have been performed with the eva surgical systems installed.Please note that a fop65541 error message will not always lead to a prolonged surgery.

Event Description

We have been informed during procedure the pedal stopped working.No actual patient harm occured.Surgery was prolonged > 30 minutes.

• Brand Name: EVA, COMBINED MACHINE NCBF INCLUDING LASER (DORC CONNECTOR)
• 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: petra holland ; scheijdelveweg 2; zuidland, 3214 -VN ; NL 3214 VN
• MDR Report Key: 16377448
• MDR Text Key: 309558799
• Report Number: 1222074-2023-00008
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• 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