MAUDE Adverse Event Report: D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV EVA TDC VITRECTOMY PACK VGPC INPUT 23G

Catalog Number	8310.23G02
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Eye Injury (1845); Intraocular Pressure, Delayed, Uncontrolled (1936); Retinal Injury (2048); Vitritis (2181)
Date of Event	02/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample has been returned and is currently under investigation.A supplemental will be reported when any new information is received.
Event or Problem Description
This event occurred during surgery for a retinal detachment.Pressure within the eye could not be maintained.Choroidals occurred continually with any type of aspiration.Staff checked the stop cock for an air lock.The pressure was adjusted and aic to above normal ranges in an attempt to maintain pressure.The bottle of bss was "shook." it was then identified that the metal snorket/bss portion of the tubing may have been blocked by glue or possibly bent.This case was completed with use of this pack and after the bottle was "shook" pressure was maintained during aspiration.It was learned that post op on the following day, the retina detached and folded.It was reported that the surgeon did not attribute this to the pack/infusion issue.A sample is available for evaluation.We have reached out to the surgeon.The following has been reported.Were the choroidals present prior to surgery? no; we have documented exam and ultrasound that there were no choroidals present.Were the choroidals present and then aggravated by surgery? no; as above; they happened during surgery; could the choroidals be due to an underlying medical condition? no; she had a giant retinal tear but to my knowledge no reason to have choroidal; did the choroidals require any treatment? no; did the choroidals self-resolve? still waiting for it to resolve; what medications were used and what medication was the patient currently taking? - could medical history have played a part? no; did the patient receive any treatment, follow up treatment or medication for the choroidals? waiting for the gas to disappear; at this time, retina is attached without issues; shallow choroidal still present; will wait to see if it improves as her retina is attached an there is adequate pressure in the eye.

• Brand Name: EVA TDC VITRECTOMY PACK VGPC INPUT 23G
• Common Device Name: EVA TDC VITRECTOMY PACK VGPC INPUT 23G
• Manufacturer (Section D): D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV; scheijdelveweg 2; zuidland, netherlands ; NL
• MDR Report Key: 7365334
• Report Number: 1222074-2018-00055
• Device Sequence Number: 2156768
• Product Code: HQE
• UDI-Device Identifier: 08717872021010
• UDI-Public: 08717872021010
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K142877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 02/19/2018

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?: Yes
• Operator of Device: Physician
• Device Catalogue Number: 8310.23G02
• Device Lot Number: 2000389196
• 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: 02/19/2018
• Initial Report FDA Received Date: 03/23/2018
• 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