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 Problems Visual Prompts will not Clear (2281); Output Problem (3005)

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

Event Date 04/01/2023

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 after completing priming and during procedure, a message car160 was triggered.Despite many attempts to prime during the surgery (while the instruments inside the patients eye) the surgeon was unable to solve the issue.No report that actual patient or user harm occurred but the surgery was prolonged > 30 min.

Manufacturer Narrative

In regard to this complaint, logfiles were provided for review but unfortunately the involved pump module was not provided for investigation.Review of the logfiles confirmed the occurrence of the reported car160 error message.However, without the return of the involved pump module, we are unable to conduct a physical investigation to determine the source of the reported car160 error message.Review of the complaint database indicated that no similar complaints have been logged on this eva surgical system until today.Since no repeat failures have been logged, it is not likely this complaint can be attributed to a defect of the eva surgical system subject to this complaint.However this cannot be determined conclusively.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.Since no (manufacturer related) product failure could be confirmed, any remedial action/corrective action/preventive action/field safety corrective action (fsca) was deemed not necessary.All similar incidents related to the eva surgical system are included in the analysis (pu-error-*).Since 2021 more than (b)(6) surgeries have been performed with the eva surgical systems installed.Please note that the failure codes will not always lead to a prolonged/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 after completing priming and during procedure, a message car160 was triggered.Despite many attempts to prime (while the instruments inside the patients eye) the surgeon was unable to solve the issue.No report that actual patient or user harm occurred but the surgery was prolonged > 30 min.

• 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: 18808868
• MDR Text Key: 337626149
• Report Number: 1222074-2024-00004
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: IZ
• 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: 04/25/2024

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: 02/29/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1