MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA EVA, COMBINED MACHINE NCBF INCLUDING LASER (DORC CONNECTOR); PHACOEMULSIFICATION/VITRECTOMY SYSTEM

Model Number 8000.COM03

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); Collapse (2416)

Event Type  Injury  

Manufacturer Narrative

Log files log the eva system were received by (b)(4).Investigation will be initiated as soon as possible.

Event Description

Two incidences on the same machine whereby the patients eye was collapsed.The infusion indicated 30-40 mmhg but eye collapsed.They frantically raised the pressure to 60-70 mmhg but no luck.One patient had a choroidal injury.Ms.(b)(6) has a video of the incident.

Event Description

Two incidences on the same machine whereby the patients eye was collapsed.The infusion indicated 30-40 mmhg but eye collapsed.They frantically raised the pressure to 60-70 mmhg but no luck.One patient had a choroidal injury.Ms.Ivanova has a video of the incident.

Manufacturer Narrative

With regard to this complaint, all used instruments that are a part of the fluid path and the log files (including surgical settings) of the eva system were requested by d.O.R.C.Only the log files were provided by the customer.Analysis of the log files did not reveal any error code relating to issues that could cause an eye to collapse.In fact, the log files did not show any abnormalities in the functioning of the machine.In addition, the air/infusion pressure test and the vacuum of the vitrectomy port test were performed (according to the d.O.R.C.'s test reports) by our technical application engineer at the site.Results of these tests were within specifications and no functional anomalies were found.The investigation findings do not lead to a clear conclusion about the cause of the reported event.

• Brand Name: EVA, COMBINED MACHINE NCBF INCLUDING LASER (DORC CONNECTOR)
• Type of Device: PHACOEMULSIFICATION/VITRECTOMY SYSTEM
• Manufacturer (Section D): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA; scheijdelveqeg 2; zuiland, 3214 VN; NL 3214 VN
• MDR Report Key: 9210001
• MDR Text Key: 164713271
• Report Number: 1222074-2019-00035
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup

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?: No
• Device Operator: No Information
• Device Model Number: 8000.COM03
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/18/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/17/2020
• Patient Sequence Number: 1