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 04/12/2023

Event Type  malfunction  

Manufacturer Narrative

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 phaco procedure, the machine was giving random errors on diathermy and vfi pressure.The surgeon could not identify the issues.Due to this, the surgery was aborted.No report that actual patient harm occurred.

Manufacturer Narrative

Review of the logfiles revealed the occurrence of multiple pum90v error messages.This error message occurs if the vgpc is not connected or not properly connected to the unit.This issue could not be solvable if the connector is damaged/defective.Other error messages were observed as well but got resolved.It was recommended to test the unit properly to see if there are problems with the unit or if these errors might have been user errors.Unfortunately, the complaint cannot be further investigated nor confirmed as nothing was 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 (eva-defect-).Since 2020 more than (b)(4) surgeries have been performed with the eva surgical systems installed.Please note that the failure code eva-defect- will not always lead to a delayed surgery.Please note that while the 2023 incident numbers are up to date, the 2023 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.

Event Description

We have been informed that during phaco procedure, the machine was giving random errors on diathermy and vfi pressure.The surgeon could not identify the issues.Due to this, the surgery was aborted.No report that actual patient harm occurred.

• 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: 17180941
• MDR Text Key: 317952242
• Report Number: 1222074-2023-00051
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: 08/17/2023

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 Catalogue Number: 8000.COM05
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1