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 Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The white stains might be caused by the curing of the cyanoacrylate glue.This is the vapor of the glue.White stains on the instrument is concluded as reportable.This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer (dutch ophthalmic research centre b.V.).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
A report from (b)(6) has been received.The following has been reported: discovered white stains on the trocars (the knife as well and the shaft).All information has been disclosed.

• 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: 7431170
• Report Number: 1222074-2018-00073
• Device Sequence Number: 1977003
• 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: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: 8523.207
• Device Lot Number: 2000366870
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2015
• Initial Report FDA Received Date: 04/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1