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	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Assuming worst case during surgery, (patient harm), failing of foot pedal during surgery can lead to huge delay in surgery, hence reportable.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) 2017.All available information has been disclosed.This complaint has now been closed.
Event or Problem Description
Foot pedal stopped working in middle of case while cabled to eva.Customer not able to connect foot pedal wirelessly.Restarted machine, still received error code fop3102 but was able to resolve error code and continue case.New foot pedal will be sent.

• 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: 7589137
• Report Number: 1222074-2018-00177
• Device Sequence Number: 1424469
• Product Code: HQC
• UDI-Device Identifier: 08717872019666
• UDI-Public: 08717872019666
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K142877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/16/2016

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.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: 06/16/2016
• Initial Report FDA Received Date: 06/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1