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

Catalog Number 8000.COM05

Device Problems Smoking (1585); Temperature Problem (3022)

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

Event Date 12/06/2021

Event Type  malfunction  

Manufacturer Narrative

The complaint is under investigation.

Event Description

It was reported that at the time of replacing the pump module, while turning the pump on, a burning smell is observed coming from the pump.No actual patient harm or operator harm occurred.

Manufacturer Narrative

In regard to this event an eva pump module was returned for investigation.Investigation of the returned module revealed a burn mark on the power converter of the mainboard of the pump module.Historical review of the complaint database indicated that no similar complaints have been logged on the eva surgical system subject to this complaint.Based on the investigation findings it was determined that the issue occurred due to a component failure of the power converter on the mainboard of the pump module.Trend analysis indicates that the product is performing within anticipated rates.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 at the time of replacing the pump module, while turning the pump on, a burning smell is observed coming from the pump.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: 13050722
• MDR Text Key: 282545117
• Report Number: 1222074-2021-00103
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1