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

Model Number 8000.COM02

Device Problems Device Emits Odor (1425); Output Problem (3005)

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

Event Type  malfunction  

Manufacturer Narrative

The unit will be returned to the manufacturer for investigation.

Event Description

A strong odor of smoke was detected coming from the back of eva, then the phaco module stopped working.The surgery was completed with another device.No patient harm occurred.

Event Description

A strong odor of smoke was detected coming from the back of eva, then the phaco module stopped working.The surgery was completed with another device.No patient harm occurred.

Manufacturer Narrative

With regards to this event, a phaco diathermy module was received for investigation.Investigation of the returned module revealed a loose connection between the phaco connector and the pcb.No traces of burning were observed.Historical review of the complaint database indicated that no similar complaints have been logged on the eva surgical system subject to this complaint.Additionally, a dhr review did not reveal any anomalies.Based upon the investigation performed, the reported odor of smoke could not be confirmed.The root cause for the loose pcb connections identified is considered to be attributed to a random component failure.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: PHACO-EMULSIFICATION/VITRECTOMY SYSTEM
• Manufacturer (Section D): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.; scheijdelveweg 2; zuidland, ; NL
• MDR Report Key: 10793675
• MDR Text Key: 216766822
• Report Number: 1222074-2020-00076
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup

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 Model Number: 8000.COM02
• Device Catalogue Number: 8000.COM02
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/05/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/11/2020
• Patient Sequence Number: 1