MAUDE Adverse Event Report: D.O.R.C INTERNATIONAL EVA VITRECTOMY PACK VGPC INPUT 23G

Catalog Number	8300.23G02
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	02/06/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Performance varies in- and out-of-specification.We have extensively tested vitrectomy.Our r & d department has made a change.As was already indicated in the (b)(4), the new vitrectomy will soon be available.Our csc department can tell when the new series is available.No further information available.This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer.(b)(4).There is limited information and no information on the outcome of this patient.
Event or Problem Description
This incident occurred during surgery.Air bubbles were observed and caused injury to patients eye, hence this complaint is concluded as reportable.There is no further information on the injury or the outcome.No product was returned for evaluation.

• Brand Name: EVA VITRECTOMY PACK VGPC INPUT 23G
• Common Device Name: EVA VITRECTOMY PACK VGPC INPUT 23G
• Manufacturer (Section D): D.O.R.C INTERNATIONAL; scheijdelveweg 2; zuidland, netherlands 3214 VN; NL 3214 VN
• MDR Report Key: 6945519
• Report Number: 1222074-2017-00013
• Device Sequence Number: 1460814
• Product Code: HQE
• UDI-Device Identifier: 08717872019000
• UDI-Public: 08717872019000
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: 8300.23G02
• Device Lot Number: 2000360916
• 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: 02/06/2014
• Initial Report FDA Received Date: 10/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other