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 Code Available (3191)
Date of Event	08/09/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Main voltage of foot pedal is too low ((b)(4)).Pcb holder changed 2 times, main pedal changed 5 times & stopped surgery, hence can be concluded as reportable.Information suggests this occurred during surgery required transfer of the patient to another unit for completion of the surgery.This is a delay and placed this patient at risk.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) 201 there is no information that reasonably suggests patient injury occurred.All available information has been disclosed.This complaint has now been closed.
Event or Problem Description
They stop the surgery and transfer the patient.Pcb holder charged 2 times, main pedal changed 5 times.Fop error blockage during surgery.In a review the information reasonably suggests that this patient was undergoing surgery when the incident occurred and the patient was transferred to another unit for completion of the surgery.All information has been disclosed.

• 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: 7616007
• Report Number: 1222074-2018-00191
• Device Sequence Number: 1422628
• Product Code: HQC
• UDI-Device Identifier: 08717872019659
• UDI-Public: 08717872019659
• 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: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: 8000.COM02
• Device Catalogue Number: 8000.COM02
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2016
• Initial Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other