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

Model Number	8000.COM03
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2017
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 (dutch ophthalmic research (b)(4)).Details of this activity were discussed with (b)(4) office of compliance (b)(4) during a tele-conference on "05/31/201." assuming worst case during surgery, this may cause injury to the patient, hence it is reportable.The risk is possible retinal ischemia.There is information if the patient was harmed.All available information has been disclosed.This complaint has now been closed.
Event or Problem Description
The iop (irrigation pressure) on the machine reached to maximum 150mmhg by itself during the procedure.This can cause too critical medical complications.No error messages.

• 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: 7669602
• Report Number: 1222074-2018-00230
• Device Sequence Number: 1370341
• Product Code: HQC
• UDI-Device Identifier: 08717872019666
• UDI-Public: 08717872019666
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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): 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• 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: 03/03/2017
• Initial Report FDA Received Date: 07/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1