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

Catalog Number 8000.COM02

Device Problems Mechanics Altered (2984); Activation Failure (3270); Noise, Audible (3273)

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

Event Date 03/14/2021

Event Type  malfunction  

Manufacturer Narrative

The device involved in the incident is being returned for investigation.

Event Description

It was reported that during a procedure, there was no activation of the vitrectome and a slight noise was coming from the vitrectomy module.The procedure was aborted due to this event.

Manufacturer Narrative

With regard to this event, an eva vitrectomy module was returned for investigation.Investigation of the returned module revealed that one of the cutter valves failed and was stuck in a closed position.Though the eva system will pass the priming phase, the cutter will not be activated because the valve is stuck in the closed position.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, it was determined that this event occurred due to a random component failure of a valve inside the vitrectomy module.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.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 during procedure, there was no activation of the vitrectome and a slight noise was coming from the vitrectomy module.The procedure was aborted due to this event.

• 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
• MDR Report Key: 11645568
• MDR Text Key: 246451043
• Report Number: 1222074-2021-00023
• 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
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 8000.COM02
• Patient Sequence Number: 1