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

Model Number	8000.COM02
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was reviewed during the retrospective review.Investigation showed a defective battery, this can happen after a long time of wired use.After replacing the battery, the foot pedal is working according specifications again.This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer (dutch ophthalmic research centre(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
Failure footpedal, footpedal went dead and will even not work when it is plugged in.New footpedal will be sent.Module (b)(4) will be returned.
Additional Manufacturer Narrative
The investigation has started.A supplemental will be submitted with any new information.
Event or Problem Description
Continous problems of collapses in both retina and cataract surgery.The patient was not injured, however, during a cataract surgery there was an important collapse that could have damaged the patient's eye.
Additional Manufacturer Narrative
Final conclusion: investigation of the returned vfie module could not reproduce the complaint.The vfie module is functioning within specifications.The provided log files have been reviewed and there are no indications that could lead to a collapsed eye.Furthermore: the eva system controls the pressure of fluids or gases that can be provided using the system.It also controls the back flush.The eva system provides feedback to the surgeon on the device performance.The eva system is tested and compliant with iec 80601 medical electrical equipment part: 2-58:2015 particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery.The eva system is a device for professional use only with the surgeon present and activating the device during the use.The device provides feedback on the performance of the system; the surgeon monitors the effect on the patient.There are no malfunctions of the device that are beyond the response (reaction time) of the surgeon.The surgical procedure with the use of the eva system can be stopped and restarted at any time during the surgical procedure to mitigate any degradation of performance out of specification.Therefor there is no unacceptable risk associated with the failure or degradation of functions or features of the lens removal devices and vitrectomy devices.Final comments from the manufacturer: the customer let us know that after the vfie module was changed for investigation reasons, several surgical sessions of phaco and two retinal sessions have been made without incident and the problem is considered solved.The replacement vfie module stays part of the machine concerned.

• 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: 7552853
• Report Number: 1222074-2018-00160
• Device Sequence Number: 16659684
• Product Code: HQC
• UDI-Device Identifier: 08717872019666
• UDI-Public: 08717872019666
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: SP
• PMA/510(K) Number: K142877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/16/2018

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: Health Professional
• Device Model Number: 8000.COM02
• Device Catalogue Number: 8000.COM02
• 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: 03/10/2016
• Supplement Date Received by Manufacturer: 05/18/2018; 08/16/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 05/30/2018; 08/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1