MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV EVA, COMBINED MACHINE

Model Number	8000.COM01
Medical Device Problem Codes	Increase in Pressure (1491); Pressure Problem (3012)
Health Effect - Clinical Code	Corneal Edema (1791)
Date of Event	02/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has started.
Event or Problem Description
A clinic in (b)(6) has reported corneal edema after surgery.There is no further detailed information at this time.We have reached out for additional information and a follow up will be submitted should any new information be received.
Additional Manufacturer Narrative
The investigation has started.
Event or Problem Description
It was also reported by the surgeon that during eye surgery, the surgeon experienced high irrigation pressure into the eye.Cornea edema appeared.We are in the process of gathering additional information.
Additional Manufacturer Narrative
For the observed edema several root causes are feasible but in investigation of the unit log files no anomalies have been identified.Based upon questions to the customer, it was not possible to identify cases where vgpc kits were erroneously used whilst the unit was in gravity mode.The customer indicated that vgpc mode was used.Eva has been tested and is certified according to iec 80601-2-58.The design of the eva contains several safety measures related to the control of the pressure that is provided by the machine.Above a pressure setting of 60 mmhg the eva provides a visual and acoustic alert which can not be switched off.Log files of the surgeries concerned did not show any anomalies on the working of eva.
Additional Manufacturer Narrative
Root cause investigation: 1.Dorc personnel has visited and observed the surgeon's operation, it was noticed that the customer uses very tight i / a irrigation flow, seems the pressure was high to irrigate the eye.2.Dorc have also reviewed the log files returned from the subject eva.It can be seen in the log files records that: only 21 surgeries were performed with the system.Vpgc and gravity modes were both set by the surgeons.The maximum irrigation pressure set by the surgeons was at 70 mmhg, which is not extremely high, and are generally used during surgery.However, the actual irrigation pressure into the air can be different from the pre-set value of eva system.The irrigation pressure could be too high if gravity is selected, while vgpc infusion accessories were connected, the later enables additional compressed air goes into the infusion bottle, while the infusion bottle was hang up at a relatively higher level, which will increase (accumulated up) the irrigation pressure higher than the preset pressure value than 70mmhg.Thus, to further investigate above assumption could be the root cause, we will check which packs were sent to the customer (only vgpc or also gravity packs of accessories).In a review the surgery experienced high irrigation pressure, most likely they were user operational errors, that the surgeons are not aware of how to use the eva gravity and vgpc modes.More investigation results will be reported in a next report.Dorc personnel has adjusted the pressure setting parameters.Instruct the surgeons on how to use the eva gravity and vgpc modes and pressure setting.
Event or Problem Description
New information has been received: the edema was reduced a few hours after the surgery.The surgeon did not prescribe any medication nor remedial interventions to the patient.

• Brand Name: EVA, COMBINED MACHINE
• Common Device Name: EVA, COMBINED MACHINE
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7300107
• Report Number: 1222074-2018-00035
• Device Sequence Number: 11219408
• Product Code: HQC
• UDI-Device Identifier: 08717872019642
• UDI-Public: 08717872019642
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K142877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/27/2018

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: Physician
• Device Model Number: 8000.COM01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2018
• Supplement Date Received by Manufacturer: 02/27/2018; 04/18/2018; 07/27/2018
• Initial Report FDA Received Date: 02/27/2018
• Supplement Report FDA Received Date: 02/27/2018; 05/18/2018; 07/27/2018
• 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: Other