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

Catalog Number	8000.COM03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Vision (2139)
Date of Event	10/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A service report has been completed.The light source module was checked to ensure that it was within limits and was found to be within limits.The illumination module is within specification.This incident is currently under investigation.A supplemental will be submitted when complete.
Event or Problem Description
A facility reports a concern with our machine and wants to know if we are aware of any cases of phototoxicity.The facility reports a case with widespread rpe wipeout.They had been using the light at 100%, and request that maybe someone from our company takes a look at the incident.In speaking with the facility, we learn that a subject underwent eye surgery for a combined rhegmatogenous retinal detachment with tractional retinal detachment.Before the surgery, his visual acuity had remained good until approximately one week ago, when he developed a rhegmatogenous component.Four days ago the subject received an intravitreal avastin injection to help with regression of neovascularization.The visual acuity rapidly declined drastically.Vitrectomy surgery was performed to improve the subject's vision.The patient then underwent the surgical procedure.It was reviewed that during the operation, there was folding of the retina, and the retinal detachment was very bullous with multiple areas of retinal breaks.An air-fluid exchange was performed visualization was lost due to due to the development of instantaneous cataracts which were drained.Each of the sclerotomies had leaking of oil as they were closed.The subject was seen by the surgeon 24 hours after the surgery on a routine basis.It is unknown at what time a question that this subject has a possible case of phototoxicity with rpe change.Additional information regarding this case includes the procedure was approximately 5 hours in length.At the end of the surgery, the intraocular pressure measured at eight mmhg and documented as "it felt somewhat soft." the patient was asked to maintain a prone position post-op for the next 24 hours.The corneal epithelium was scraped during the procedure.The surgery was complete; no additional medication was prescribed other than the routine post-op med.The surgeon has reported a vision loss.The vision is now 20/400 post surgery.
Additional Manufacturer Narrative
The investigation of the eva system did not identify any abnormalities.However, photo toxicity is a known risk related to this kind of procedure.A known contributing factor to this risk of photo toxicity is exposure time to the light.Safe exposure times are described in detail in the user manual of eva (doc.(b)(4), version date (b)(6) 2017, page 112).Our conclusion is that the eva unit performed consistently with its specifications in these cases and a product malfunction or failure did not contribute to the unfortunate outcome of the procedures.

• 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; p.o. box 43; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7386010
• Report Number: 1222074-2018-00058
• Device Sequence Number: 13726828
• Product Code: HQE
• UDI-Device Identifier: 08717872002910
• UDI-Public: 08717872002910
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K142877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Catalogue Number: 8000.COM03
• Device Lot Number: 2015000549
• 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: 03/07/2018
• Supplement Date Received by Manufacturer: 07/11/2018; 07/27/2018
• Initial Report FDA Received Date: 03/30/2018
• Supplement Report FDA Received Date: 07/11/2018; 07/30/2018
• 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: Disability
• Patient Age: 33 YR