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

Model Number	8000.COM02
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The unit is going to bootloader mode itself during surgery, this issue cannot be solved right away hence considered as reportable.(b)(4).All available information has been disclosed.The complaint is not confirmed.This complaint has now been closed.
Event or Problem Description
Mainboard is going to bootloader modus by itself during shaving (near retina ) procedure.All went red and unit must be switched off from backside during surgery.

• Brand Name: EVA, COMBINED MACHINE INCLUDING LASER (DORC CONNECTOR)
• Common Device Name: EVA, COMBINED MACHINE INCLUDING LASER (DORC CONNECTOR)
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7541299
• Report Number: 1222074-2018-00152
• Device Sequence Number: 217496
• Product Code: HQC
• UDI-Device Identifier: 08717872019659
• UDI-Public: 08717872019659
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 02/17/2016

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: Physician
• Device Model Number: 8000.COM02
• Device Catalogue Number: 8000.COM02
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2016
• Initial Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1