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

Catalog Number 8000.COM05

Device Problem Smoking (1585)

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

Event Date 06/30/2021

Event Type  malfunction  

Manufacturer Narrative

The product will be returned for investigation.

Event Description

It was reported that, prior to use, the eva switched off by itself and smoke was smelled coming from the mainboard from the machine.No actual patient harm or operator harm occurred.

Manufacturer Narrative

No corrective or preventive actions can be implemented until the investigation has been completed.Following up on this event, the customer was requested to returned the item subject to this even for investigation.A confirmation that the product will be returned for investigation was received.However, we are still awaiting the system to arrive at our facility.After return of the item, (root) cause investigation will be performed.Following up on this event, the customer was requested to returned the item subject to this even for investigation.A confirmation that the product will be returned for investigation was received.However, we are still awaiting the system to arrive at our facility.After return of the item, (root) cause investigation will be performed.

Event Description

It was reported that, prior to use, the eva switched off by itself and smoke was smelled coming from the mainboard from the machine.No actual patient harm or operator harm occurred.

Manufacturer Narrative

Following up on this event, the customer was requested to returned the item subject to this even for investigation.A confirmation that the product will be returned for investigation was received.However, we are still awaiting the system to arrive at our facility.After return of the item, (root) cause investigation will be continued.

Event Description

It was reported that, prior to use, the eva switched off by itself and smoke was smelled coming from the mainboard from the machine.No actual patient harm or operator harm occurred.

Manufacturer Narrative

In regard to this event an eva surgical system was inspected on location.On-site inspection revealed that the mainboard of the eva surgical system smelt burned.The issue was resolved by replacement of the mainboard.Unfortunately the mainboard will not be available for in depth investigation due to an issue with the local customs.Based on the available information an issue with the mainboard can be confirmed.However, since no product was returned, a cause could not be determined conclusively for this event.Review of the complaint database indicated that no similar complaints have been logged on the eva surgical system subject to this complaint until today.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.The risk identified is included in the risk management documentation.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.Since 2018 more than 750.000 surgeries have been performed with the eva surgical systems installed.

Event Description

It was reported that, prior to use, the eva switched off by itself and smoke was smelled coming from the mainboard from the machine.No actual patient harm or operator harm occurred.

Manufacturer Narrative

The product will be returned for investigation.No corrective or preventive actions can be implemented until the investigation has been completed.Following up on this event, the customer was requested to returned the item subject to this even for investigation.A confirmation that the product will be returned for investigation was received.However, we are still awaiting the system to arrive at our facility.After return of the item, (root) cause investigation will be performed.

Event Description

It was reported that, prior to use, the eva switched off by itself and smoke was smelled coming from the mainboard from the machine.No actual patient harm or operator harm occurred.

Manufacturer Narrative

The product will be returned for investigation.No corrective or preventive actions can be implemented until the investigation has been completed.Following up on this event, the customer was requested to returned the item subject to this even for investigation.A confirmation that the product will be returned for investigation was received.However, we are still awaiting the system to arrive at our facility.After return of the item, (root) cause investigation will be performed.

Event Description

It was reported that, prior to use, the eva switched off by itself and smoke was smelled coming from the mainboard from the machine.No actual patient harm or operator harm occurred.

• 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: 12248275
• MDR Text Key: 264163095
• Report Number: 1222074-2021-00059
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: IR
• 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: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• 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
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1