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

Catalog Number 8000.COM02

Device Problems Insufficient Flow or Under Infusion (2182); Infusion or Flow Problem (2964)

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

Event Date 11/13/2023

Event Type  malfunction  

Manufacturer Narrative

The complaint is under investigation.No corrective or preventive actions can be implemented until the investigation has been completed.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, before beginning the phaco procedure, it was noticed that water was coming out of the handpiece but constant irrigation is off.After restarting, the machine refused to prime and the screen showed an error message.A new cartridge was opened but it had the same problem.The phaco was completed using another machine.Surgery was prolonged more than 30 minutes.No report that actual patient harm occurred.

Manufacturer Narrative

In regards to this complaint, no logfiles were provided and the pump module was not returned to d.O.R.C.Therefor a logfile review or physical investigation could be not be performed in order to determine the source of the reported pum61 error message.The reported error "pum61" indicates that no irrigation pressure is measured during the start of the priming.Based on the the reported pum61 error, the incident could be related to the clip not being opened, or there could be a congestion/blockage/kink in the tubing itself or a blocked spike.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 (pu-pum61_*).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 prolonged surgery.

Event Description

We have been informed that during surgery, before beginning the phaco procedure, it was noticed that water was coming out of the handpiece but constant irrigation is off.After restarting, the machine refused to prime and the screen showed an error message.A new cartridge was opened but it had the same problem.The phaco was completed using another machine.Surgery was prolonged more than 30 minutes.No report that actual patient harm occurred.

Manufacturer Narrative

It is unknown if the product will be returned at this point.No corrective or preventive actions can be implemented until the investigation has been completed.A product return reminder has been sent to receive the device for investigation.If the device is not available for investigation, the incident will be investigated from the log files.

Event Description

We have been informed that during surgery, before beginning the phaco procedure, it was noticed that water was coming out of the handpiece but constant irrigation is off.After restarting, the machine refused to prime and the screen showed an error message.A new cartridge was opened but it had the same problem.The phaco was completed using another machine.Surgery was prolonged more than 30 minutes.No report that actual patient harm occurred.

• Brand Name: EVA, COMBINED MACHINE 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: 18418399
• MDR Text Key: 331593969
• Report Number: 1222074-2023-00089
• 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,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8000.COM02
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1