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	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/28/2015
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 (dutch ophthalmic research centre (b)(4)).Details of this activity were discussed with cdrh office of compliance ((b)(6)) during a tele-conference on 05/31/2017.The associated risk is injury by microbial, viral or prion infection (patient harm) or large bubbles in the eye.The quick movement of the inner and outer knife will probably create the bubbles.All available information has been provided.This complaint is not confirmed.This complaint has now been closed.
Event or Problem Description
"this pack had a vitrectome that is introducing large amount of bubbles into the eye during vitrectomy.Cutter had to be discarded due to contamination by patient use.Please investigate the lot number to see if it is batch error with the cutters.

• 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: 7359708
• Report Number: 1222074-2018-00050
• Device Sequence Number: 11055884
• 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,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 01/28/2015

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: 2000366429
• 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: 01/28/2015
• Initial Report FDA Received Date: 03/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1