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

Model Number 8000.COM03

Device Problem Intermittent Energy Output (4025)

Patient Problem Intraocular Pressure, Delayed, Uncontrolled (1936)

Event Type  malfunction  

Manufacturer Narrative

Investigation has been initiated.

Event Description

Extrusion would not work or would only work sporadically.With both orange and red extrusions.Further, a complete loss of intraocular pressure was experienced.

Manufacturer Narrative

A complaint was filed about problems with irrigation and aspiration on the eva system.No patient harm was reported.As precaution the pump module and vfie module were replaced.After the replacement the d.O.R.C.Representative was present on-site and witnessed three cases (combo surgeries) and reported all was working fine.The logfiles of the eva system which had the alleged problems were analyzed by dorc r&d department.The analysis revealed that in the programmed configuration (core vitrectomy), the left side movement of the pedal was configured as micro backflush function with no aspiration available.From the logfiles it is concluded that the surgeon did actuate the pedal to the left while simultaneously pressing the pedal vertically, thus no aspiration could be activated as the micro backflush function was active all the time.As a consequence, the irrigation compensation function did not change, keeping the irrigation at the setpoint of 30 mmhg as it should.The conclusion from the analysis is that the eva system did respond to the user commands as intended.No abnormal behavior could be found.This issue has not been reported by other users, and as such no pattern of use errors is considered to be present at this point warranting further corrective action.Training on the (user configurable) buttons on the foot pedal will be offered to the surgeons at this site.

Event Description

Extrusion would not work or would only work sporadically.With both orange and red extrusions.Further, a complete loss of intraocular pressure was experienced.

• Brand Name: EVA OPHTHALMIC SURGICAL SYSTEM
• Type of Device: PHACOEMULSIFICATION/VITRECTOMY SYSTEM
• Manufacturer (Section D): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA; scheijdelveqeg 2; zuiland, 3214 VN; NL 3214 VN
• MDR Report Key: 8873623
• MDR Text Key: 153971689
• Report Number: 1222074-2019-00021
• 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

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 8000.COM03
• Patient Sequence Number: 1