MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV EVA CUSTOM TDC VITRECTOMY PACK VGPC INPUT 23G

Catalog Number	8523.207
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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).Since it is high infusion line,it is possible to lead to hypotony and reportable.We where not able to reproduce the complaint.The vitrectome is working according the specifications.All available information has been disclosed.This complaint has now been closed.
Event or Problem Description
We received a complaint that reported out of this pack: cutter did not cut, high infusion line dropped off trocar.

• Brand Name: EVA CUSTOM TDC VITRECTOMY PACK VGPC INPUT 23G
• Common Device Name: EVA CUSTOM TDC VITRECTOMY PACK VGPC INPUT 23G
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7656459
• Report Number: 1222074-2018-00221
• Device Sequence Number: 1550254
• Product Code: HQE
• UDI-Device Identifier: 08717872021287
• UDI-Public: 08717872021287
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K142877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 01/19/2017

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: 8523.207
• Device Lot Number: 2000382751
• 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: 01/19/2017
• Initial Report FDA Received Date: 07/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1