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

Catalog Number 8000.COM03

Device Problem Smoking (1585)

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

Event Date 04/28/2022

Event Type  malfunction  

Manufacturer Narrative

The complain is under investigation.

Event Description

It was reported that during procedure, a burning smell was observed coming from machine.No actual patient harm or operator harm occurred.

Event Description

It was reported that during procedure, a burning smell was observed coming from machine.No actual patient harm or operator harm occurred.

Manufacturer Narrative

With regard to this an eva surgical system was inspected on location.During inspection performed the reported event could not be reproduced and the eva surgical system passed the final release test including the electrical safety test.Review of the complaint database indicated that no similar events have been logged on this surgical system until today.In addition, follow-up with the local application specialist indicated that the eva surgical system involved functions as anticipated without any issues since the date of the reported event.Furthermore, it was indicated that the site was unsure whether the burning smell was attributable to the eva system involved.Based upon the investigation results (i.E.No anomalies identified during functional inspection included an electrical safety test and other issues reported since time of occurrence) it is highly unlikely that the burning smell originated from the eva surgical system.Therefore, the reported event is not considered attributable to the eva surgical system involved.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.

• 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: 14406428
• MDR Text Key: 299786247
• Report Number: 1222074-2022-00042
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 06/27/2022

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.COM03
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1