MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA EVA, COMBINED MACHINE INCLUDING LASER (DORC CONNECTOR); PHACOEMULSIFICATION/VITRECTOMY SYSTEM

Model Number	8000.COM02
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The surgery was completed with this device with no injury.The investigation has been started.
Event or Problem Description
The head surgeon indicates, that at several occasions during surgery, he saw the blood vessels contracting and felt that the pressure is much higher than the 20mmhg displayed in the settings.He was questioning if the bottle pressure displayed is correct.
Additional Manufacturer Narrative
The machine concerned did not arrive yet at d.O.R.C.For investigation (expected week 40, 2018).Investigation will start as soon as machine arrived.
Event or Problem Description
The head surgeon indicates, that at several occasions during surgery, he saw the blood vessels contracting and felt that the pressure is much higher than the 20mmhg displayed in the settings.He was questioning if the bottle pressure displayed is correct.
Additional Manufacturer Narrative
Follow up 16 august 2018: d.O.R.C.Received multiple complaints on the machine concerned.Although during a technical service visit to the location no anomalies could be found, it has been decided to replace the machine.Investigation is being conducted on the returned machine.
Additional Manufacturer Narrative
The eva system controls the pressure of fluids or gases that can be provided using the system.It also controls the back flush.The eva system provides feedback to the surgeon on the device performance.The eva system is tested and compliant with iec 80601 medical electrical equipment part 2-58:2015 particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery.To find out the root cause of the reported issue, the following tests were performed: 1) cartridge pump (tests on infusion, constant irrigation, measured aspiration and infusion vgpc); 2) posterior module (tests on air and vgpc).These tests extensively challenge the fluidic pressure control systems of eva, and included measurement of the pressures delivered by the machine.From these tests, no anomalies relevant to the reported issues were found.All tests passed the expected outcome and a cause for the reported issue was not found.The eva concerned is operating as intended.At this point, despite extensive testing and given the subjective nature of the complaint dorc is unable to offer an alternative explanation for the reported issues.D.O.R.C.Has made extensive efforts to reproduce the reported complaints on this machine, but the machine is operating within normal parameters.Dorc will continue to monitor the performance of both this machine and also other machines that may be in operation at this customer, and will raise further reports should information material to this case emerge.- attachment: [mir44580_final_signed follow up 3.Pdf].
Event or Problem Description
The head surgeon indicates, that at several occasions during surgery, he saw the blood vessels contracting and felt that the pressure is much higher than the 20mmhg displayed in the settings.He was questioning if the bottle pressure displayed is correct.

• Brand Name: EVA, COMBINED MACHINE INCLUDING LASER (DORC CONNECTOR)
• Common Device Name: PHACOEMULSIFICATION/VITRECTOMY SYSTEM
• Manufacturer (Section D): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA; scheijdelveqeg 2; 3214 vn; zuiland, netherlands 3214 VN; NL 3214 VN
• MDR Report Key: 7526214
• Report Number: 1222074-2018-00137
• Device Sequence Number: 1438573
• Product Code: HQC
• UDI-Device Identifier: 08717872019659
• UDI-Public: 08717872019659
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K142877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8000.COM02
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/25/2018
• Supplement Date Received by Manufacturer: 08/16/2018; 08/16/2018; 08/16/2018
• Initial Report FDA Received Date: 05/18/2018
• Supplement Report FDA Received Date: 08/17/2018; 09/27/2018; 12/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization