MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV EVA CUSTOM TDC VITRECTOMY PACK VGPC INPUT 25G

Catalog Number	8525.201
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/03/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was reviewed during the retrospective review.The investigation showed that the cartridge is working according to specifications.It is possible that this complaint is caused by the output valve of de pressure regulator in the vfie module.Please have this checked.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
The complainant informed that the infusion of the system was insufficient to maintain adequate pressure in the eye, under both fluid and air.Infusion was raised from 40 mmhg to 150 mmhg, and still produced insufficient globe pressure.The infusion line was replaced and the case was completed at 150 mmhg (which is high).The surgeon insisted the pressure was insufficient throughout the case.The complaint item will be returned.

• Brand Name: EVA CUSTOM TDC VITRECTOMY PACK VGPC INPUT 25G
• Common Device Name: EVA CUSTOM TDC VITRECTOMY PACK VGPC INPUT 25G
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7565341
• Report Number: 1222074-2018-00165
• Device Sequence Number: 14044625
• Product Code: HQE
• UDI-Device Identifier: 08717872021294
• UDI-Public: 08717872021294
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 05/03/2016

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: Physician
• Device Catalogue Number: 8525.201
• Device Lot Number: 2000376172
• 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: 05/03/2016
• Initial Report FDA Received Date: 06/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1