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 Infusion or Flow Problem (2964)

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

Event Date 02/20/2024

Event Type  malfunction  

Manufacturer Narrative

The compaint is currently 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 the vitrectomry surgery, car151 error was notified subsequently, a cartridge replacement was carried out.Also during the oil remover operation, an error occurred, leading to the operation being halted before completion.No report that actual patient harm occurred.Surgery was aborted.

Manufacturer Narrative

The device will be returned but is not accessible for investigation yet.The investigation will be continued when the device is available for examination.

Event Description

We have been informed that during the vitrectomry surgery, car151 error was notified subsequently, a cartridge replacement was carried out.Also during the oil remover operation, an error occurred, leading to the operation being halted before completion.No report that actual patient harm occurred.Surgery was aborted.

Manufacturer Narrative

In regard to this complaint, logfiles were provided for review and a vfie module was provided for investigation.Visual inspection of the module revealed visible rusting on the inside and outside of the module.The vgpc connector also had rust on it.During start up, the module encountered the vfc214 error that signified a defective vfie pcb which was also likely damaged by fluids entering the module.Based on the investigation results, it was determined that the reported complaint is most likely attributable to an (unintended) use error.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.All similar incidents related to the eva surgical system are included in the analysis (eva-defect_).Since 2021 more than 850.000 surgeries have been performed with the eva surgical systems installed.Please note that the failure codes will not always lead to a delayed surgery.Please note that the complaint related to this manufacturer incident report is included in the complaint numbers in the table.

Event Description

We have been informed that during the vitrectomy surgery, car151 error was notified subsequently, a cartridge replacement was carried out.Also during the oil remover operation, an error occurred, leading to the operation being halted before completion.No report that actual patient harm occurred.Surgery was aborted.

• 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: 18824755
• MDR Text Key: 336803465
• Report Number: 1222074-2024-00006
• 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,Followup
• Report Date: 05/16/2024

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: 03/04/2024
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/25/2024; 05/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1