MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV EVA, COMBINED MACHINE INCLUDING LASER (SMA CONNECTOR)

Model Number	8000.COM03
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	Loss of Vision (2139)
Date of Event	09/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer ((b)(4)).Details of this activity were discussed with cdrh office of compliance ((b)(6)) during a tele-conference on (b)(6).The investigation concluded due to user error infusion line pressure varies and patient lost his sight hence reportable.All available information has been disclosed.This complaint has now been closed.
Event or Problem Description
It was happened that vit2 appeared on eva and the screen went red during vit surgery, and to clear the error they turned off, rebooted and did re-priming with infusion tubing connected with patient eye, because his nurse insisted that our young sales reps say it is possible by phone conversation.The priming completed successfully.After surgery, his patient lost the sight of his eye and requested him to submit his clinical record.The dr.Really would like to know possible impacts that might be caused by continuing to apply 100mmhg of irrigation pressure to the eye for at least 1 minute during priming.He would like to know the reason his patient lost the sight of his eye and if it was because of eva or not.The dr.Insists that the priming should not completed with infusion tubing connected with patient eye.This patient had an artery stenosis and further investigation determined that the artery stenosis was present prior to the start of the surgery.In collaboration with the physician we conclude that this is the main reason for the lost of sight by the patient.

• Brand Name: EVA, COMBINED MACHINE INCLUDING LASER (SMA CONNECTOR)
• Common Device Name: EVA, COMBINED MACHINE INCLUDING LASER (SMA CONNECTOR)
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7622147
• Report Number: 1222074-2018-00195
• Device Sequence Number: 13876763
• Product Code: HQC
• UDI-Device Identifier: 08717872019666
• UDI-Public: 08717872019666
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 09/02/2016

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.COM03
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2018
• Initial Report FDA Received Date: 06/20/2018
• 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: Disability