MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER B.V. EVA, COMBINED MACHINE NCBF INCLUDING LASER (DORC CONNECTOR); PHACOEMULSIFICATION/VITRECTOMY SYSTEM

Catalog Number 8000.COM05

Device Problem Output Problem (3005)

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

Event Date 10/10/2023

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 that during surgery, the eva machine experienced a pum71 error during priming, which indicates that no aspiration pressure possible.No report that actual patient harm occurred.However, surgery was prolonged > 30 minutes.

Event Description

We have been informed that during surgery, the eva machine experienced a pum71 error during priming, which indicates that no aspiration pressure possible.No report that actual patient harm occurred.However, surgery was prolonged > 30 minutes.

Manufacturer Narrative

In regard to this complaint, a pump module was provided for investigation.Investigation of the returned module revealed a defective vacuum sensor on the mainboard.Due to the defective sensor, the vacuum was not detected correctly which triggered the eva surgical system to present the reported pum71 error message on the screen.Based on the investigation results, it was determined that the reported complaint is attributable to a random component failure of the vacuum sensor of the pump module.The risk identified is included in the risk management documentation.Trend analysis indicates that the product is performing within anticipated rates.Complaints will be closely monitored to identify any significant adverse trends.No corrective or preventive actions will be implemented as a result of this incident.All similar incidents related to the eva surgical system are included in the analysis (pu-mainboard-vacuumsensor).Since 2021 more than 850.000 surgeries have been performed with the eva surgical systems installed.Please note that the failure code will not always lead to a prolonged/delayed surgery.Please note that while the incident numbers are up to date, the installed base figures are from (b)(6) 2023.As in general the installed base increases, the actual number of devices in the market most likely is slightly higher.

• 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 B.V.; scheijdelveweg 2; zuidland, 3214 VN; NL 3214 VN
• Manufacturer (Section G): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER B.V.; scheijdelveweg 2; zuidland, 3214 VN; NL 3214 VN
• Manufacturer Contact: petra holland ; scheijdelveweg 2; zuidland, 3214 -VN ; NL 3214 VN
• MDR Report Key: 18090641
• MDR Text Key: 327592791
• Report Number: 1222074-2023-00081
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 01/03/2024

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: Health Professional
• Device Catalogue Number: 8000.COM05
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/08/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1