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 05/10/2022

Event Type  malfunction  

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.

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.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.

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 this event an eva foot pedal was returned for investigation.Initial inspection revealed that the pedal got stuck after being pressed.In order to determine a cause for the reported event, the pedal was sent to the supplier for further 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

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 has been received back from the supplier.The investigation results from the supplier will be reviewed to finalize the root cause analysis.

Manufacturer Narrative

With regard to this event, an eva main pedal was returned for investigation.Investigation of this pedal revealed that damaged foil around its potentiometer, prevented it from coming back to its neutral position.The constant irrigation can only be toggled off when the pedal is released; in its neutral position.Therefore, the event is most likely caused by the random component failure of the pedal.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.No corrective or preventive actions will be implemented as a result of this incident as trend reporting shows the product performance is within anticipated limits, also when this random component failure is taken into account.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.

• 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: 14716883
• MDR Text Key: 302830944
• Report Number: 1222074-2022-00047
• 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: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• 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: Reuse
• Patient Sequence Number: 1