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

Model Number 8000.COM03

Device Problem Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2017

Event Type  malfunction  

Manufacturer Narrative

This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer (dutch ophthalmic research centre b.V.).Details of this activity were discussed with cdrh office of compliance ((b)(6)) during a tele-conference on (b)(6) 2018.Since this incident occurred during surgery.It can lead to hypotony.All available information has been disclosed.This complaint has now been closed.

Event Description

Machine suddenly stopped responding, the screen was frozen, it was aspirating and irrigating although no one was pressing the footswitch, there was no error message and it was impossible to turn off the machine.After rebooting the eva directly from the main switch on the back, the system entered the demo mode every time.We tried to reboot it plenty of times but it kept entering the demo mode.

• Brand Name: EVA, COMBINED MACHINE INCLUDING LASER (SMA CONNECTOR)
• Type of Device: EVA, COMBINED MACHINE INCLUDING LASER (SMA CONNECTOR)
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• Manufacturer (Section G): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• Manufacturer Contact: laura smith ; 10 continental dr; bldg 1; exeter, NH 03833 ; 6037786929
• MDR Report Key: 7664852
• MDR Text Key: 113523424
• Report Number: 1222074-2018-00223
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 08717872019666
• UDI-Public: 08717872019666
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K142877
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/26/2017

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
• Device Operator: Physician
• Device Model Number: 8000.COM03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/26/2017
• Initial Date FDA Received: 07/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1