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); Overheating of Device (1437)

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

Event Type  malfunction  

Manufacturer Narrative

The unit involved will be returned to the manufacturer for investigation.

Event Description

A slight burning smell was observed in the or behind eva during the laser coagulation, and phaco handpiece became hot, and the surgeon felt a tinkling in his hand that held the phaco handpiece.No actual harm occurred.

Manufacturer Narrative

With regard to the reported event a phaco diathermy module was returned for investigation.Investigation revealed a small burn mark on the pcb inside of the returned module.The burn mark was caused by a short circuit and probably caused the reported burnt smell.A dhr review did not reveal any anomalies and the product was released according to its release specifications.Also a historical review of the complaint database indicated that no similar complaints have been logged on the eva surgical system subject to this reported event.Based on the information available, the root cause for the short circuit could not be determined conclusively.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.

Event Description

A slight burning smell was observed in the or behind eva during the laser coagulation and phaco handpiece became hot and the surgeon felt a tinkling in his hand that held the phaco handpiece.No actual harm occurred.

Manufacturer Narrative

The unit involved will be returned to the manufacturer for investigation.No corrective or preventive actions can be implemented until the investigation has been completed.The investigation is still on-going as the unit has not been returned to the manufacturer.

Event Description

A slight burning smell was observed in the or behind eva during the laser coagulation and phaco handpiece became hot and the surgeon felt a tinkling in his hand that held the phaco handpiece.No actual harm occurred.

• 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: 11038691
• MDR Text Key: 222828079
• Report Number: 1222074-2020-00091
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8000.COM02
• Device Catalogue Number: 8000.COM02
• Patient Sequence Number: 1