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 05/19/2021

Event Type  malfunction  

Manufacturer Narrative

The product has been returned for investigation.

Event Description

It was reported that while the eva was switched off, smoke was smelled and detected coming from the mainboard from the machine.No actual patient harm or operator harm occurred.

Manufacturer Narrative

In regard to this complaint an eva mainboard was returned for investigation.Investigation of the returned mainboard revealed that the mainboard was defective due to a short circuit.Investigation could not identify the cause of the short circuit observed.Review of the complaint database indicated that no similar complaints have been logged on the eva surgical system subject to this complaint until today.Also a dhr review did not reveal any anomalies.Unfortunately, based on the investigation results, a root cause could not be determined conclusively.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.((b)(4)) 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.

Event Description

It was reported that while the eva was switched off, smoke was smelled and detected 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; zuiland, 3214V N; NL 3214VN
• Manufacturer (Section G): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.; scheijdelveweg 2; zuiland, 3214V N; NL 3214VN
• Manufacturer Contact: danielle sleegers ; scheijdelveweg 2; zuiland, 3214V-N ; NL 3214VN
• MDR Report Key: 11920751
• MDR Text Key: 253784003
• Report Number: 1222074-2021-00046
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: HU
• 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: 07/12/2021

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: No Information
• Device Catalogue Number: 8000.COM05
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/02/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/12/2021
• Type of Device Usage: N
• Patient Sequence Number: 1