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

Catalog Number	8310.23G02
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Incident occurred during surgery, vitrotome produced air bubbles which leads infection to patient which is a serious harm, hence concluded as reportable.No sample was returned, therefore unable to confirm this complaint.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)(4)) during a tele-conference on (b)(6) /2017.All available information has been provided.This complaint has now been closed.
Event or Problem Description
A report has been received of an incident occurring in (b)(6).The following was reported: the vitrectome was giving off bubbles during use and had to be replaced in order to continue the surgery.No injury to the patient.

• Brand Name: EVA TDC VITRECTOMY PACK VGPC INPUT 23G
• Common Device Name: EVA TDC VITRECTOMY PACK VGPC INPUT 23G
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7432653
• Report Number: 1222074-2018-00079
• Device Sequence Number: 1339565
• Product Code: HQE
• UDI-Device Identifier: 08717872021010
• UDI-Public: 08717872021010
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K142877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2015

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: 8310.23G02
• Device Lot Number: 2000367359
• 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: 03/27/2015
• Initial Report FDA Received Date: 04/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1