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

Model Number	8000.COM01
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The error message vit 7 was provided to the user at the preparation of the surgery: "faulty cutter detected, please replace the cutter and prime cutter again".Vit 7 error message is a designed feature of eva to protect against a fault becoming a hazard.The event did not lead to serious deterioration in state of patient health.However, the surgery cannot be started due to this error, and was rescheduled.My vitrectomy module is being sent back to dorc for investigation.The investigation results will be reported in a follow up report or a final report.
Event or Problem Description
Vit7 error occurred (faulty cutter detected) and they had to abort surgery.The patient was being anesthetized, and due to the error, the surgery cannot be started and the surgeon had to wake up the patient.The surgeon rescheduled another surgery.
Additional Manufacturer Narrative
Investigation of the returned vitrectomy module determined a loose vitrectomy connector.The module was replaced.During the startup of eva the error message vit7 occurred due to this problem.As a result of this safety warning the surgeon decided to postpone the surgery.This error message was correctly interpreted by the surgeon and as appropriate the module was not used.This complaint has now been closed.

• 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: 7481037
• Report Number: 1222074-2018-00093
• Device Sequence Number: 334078
• Product Code: HQE
• UDI-Device Identifier: 08717872019666
• UDI-Public: 08717872019666
• 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: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2018

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.COM01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2018
• Supplement Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 07/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1