MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. EVA; PHACOEMULSIFICATION/VITRECTOMY SYSTEM

Catalog Number 8000.COM08

Device Problem Improper Flow or Infusion (2954)

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

Event Date 04/21/2022

Event Type  malfunction  

Manufacturer Narrative

The complaint is under investigation.

Event Description

We have been informed that during procedure in the posterior segment, the user was unable to turn off the constant irrigation.The user was able to resolve the issue by clamping the tubing and continue the procedure.No report of patient/user harm.No report of prolonged or delayed surgery.

Manufacturer Narrative

The complaint is under investigation no corrective or preventive actions can be implemented until the investigation has been completed.With regard to this event a foot pedal was returned for investigation.Investigation to determine a cause for the reported event is ongoing.

Event Description

We have been informed that during procedure in the posterior segment, the user was unable to turn off the constant irrigation.The user was able to resolve the issue by clamping the tubing and continue the procedure.No report of patient/user harm.No report of prolonged or delayed surgery.

Manufacturer Narrative

With regard to this event, a foot pedal was returned for investigation.Investigation to determine a cause for the reported event is ongoing.

Event Description

We have been informed, that during procedure.In the posterior segment, the user was unable to turn off the constant irrigation.The user was able to resolve the issue by clamping the tubing and continue the procedure.No report of patient/user harm.No report of prolonged or delayed surgery.

Manufacturer Narrative

In regard to the reported event a foot pedal was returned for investigation.In addition, logfiles were available for review.Review of the logfiles provided confirmed the use of the constant irrigation function.Functional testing of the returned foot pedal revealed a possible issue with the functionality of the pedal involved.The pedal was sent to the supplier for further investigation.No corrective or preventive actions can be implemented until the investigation has been completed.The pedal was sent to the supplier for in depth investigation.The root cause investigation is ongoing.

Event Description

We have been informed that during procedure in the posterior segment, the user was unable to turn off the constant irrigation.The user was able to resolve the issue by clamping the tubing and continue the procedure.No report of patient/user harm.No report of prolonged or delayed surgery.

Manufacturer Narrative

With regard to this event the eva system was not returned for investigation, however logfiles were provided.Analysis of the logfiles showed that the eva system responded correctly when the constant irrigation was toggled off.However as the pedal was pressed, the constant irrigation stayed active.Review of the complaint database indicated that one similar issue has been logged on this eva surgical system since the event occurred.As the functionality of constant irrigation is used frequently and the similar incident happened a few weeks later, it is concluded that the second incident is not related to this case.Based on the logfile review, the eva system performed as intended.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-irrigation not off).Since 2019 more than 850.000 surgeries have been performed with the eva surgical systems installed.

Event Description

We have been informed that during procedure in the posterior segment, the user was unable to turn off the constant irrigation.The user was able to resolve the issue by clamping the tubing and continue the procedure.No report of patient/user harm.No report of prolonged or delayed surgery.

Event Description

We have been informed that during procedure in the posterior segment, the user was unable to turn off the constant irrigation.The user was able to resolve the issue by clamping the tubing and continue the procedure.No report of patient/user harm.No report of prolonged or delayed surgery.

Manufacturer Narrative

In regard to the reported event a foot pedal was returned for investigation.In addition, logfiles were available for review.Review of the logfiles provided confirmed the use of the constant irrigation function.Functional testing of the returned foot pedal revealed a possible issue with the functionality of the pedal involved.The pedal was sent to the supplier for further investigation.

• Brand Name: EVA
• 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: danielle sleegers ; scheijdelveweg 2; zuidland, 3214 -VN ; NL 3214 VN
• MDR Report Key: 14406141
• MDR Text Key: 300219101
• Report Number: 1222074-2022-00041
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8000.COM08
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1