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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV EVA, COMBINED MACHINE INCLUDING LASER (SMA CONNECTOR)
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DUTCH OPTHALMIC RESEARCH CENTER BV EVA, COMBINED MACHINE INCLUDING LASER (SMA CONNECTOR) Back to Search Results
Model Number 8000.COM03
Health Effect - Clinical Code No Information (3190)
Date of Event 04/04/2017
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 cdrh office of compliance (b)(4) during a tele-conference on "05/31/201" this incident occurred during surgery.Unable to proceed with the case or delay in the procedure.Therefore this complaint is concluded as reportable.All available information has been disclosed.This complaint has now been closed.
 
Event or Problem Description
Error code fop5001 device hardware.Foot pedal failed during surgery unable to proceed with case.Module will be replaced.
 
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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 Key7670532
Report Number1222074-2018-00236
Device Sequence Number848850
Product Code HQC
UDI-Device Identifier08717872019666
UDI-Public08717872019666
Combination Product (Y/N)N
Initial Reporter StateNH
Initial Reporter CountryUS
PMA/510(K) Number
K142877
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date (Section B) 04/04/2017
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 Number8000.COM03
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/04/2017
Initial Report FDA Received Date07/09/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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