MAUDE Adverse Event Report: D.O.R.C INTERNATIONAL VA VITRECTOMY PACK VGPC INPUT 25G

Catalog Number	8300.25G02
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have extensively tested vitrectome.Our r & d department has made a change.As was already indicated in the snf, the new vitrectoom will soon be available.Our csc department can tell when the new series is available.Bubbles can lead to a patient harm.Hence reportable.Performance varies in- and out-of-specification.This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer.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 provided.
Event or Problem Description
A report has been received that occurred in (b)(6).Today we faced a new and very serious issue and we are trying to understand the reasons for it.It was reported bubbles from the aspiration port of the cutter at high cut rate-shaving.There is no information of a patient injury.All information has been provided.No sample was available for evaluation.

• Brand Name: VA VITRECTOMY PACK VGPC INPUT 25G
• Common Device Name: VA VITRECTOMY PACK VGPC INPUT 25G
• Manufacturer (Section D): D.O.R.C INTERNATIONAL; scheijdelveweg 2; vigilance@dorc.eu; zuidland, netherlands 3214 VN; NL 3214 VN
• MDR Report Key: 6950402
• Report Number: 1222074-2017-00020
• Device Sequence Number: 1222318
• Product Code: HQE
• UDI-Device Identifier: 08717872019024
• UDI-Public: 08717872019024
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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): 05/20/2014

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: 8300.25G02
• Device Lot Number: 2000358476
• 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: 05/20/2014
• Initial Report FDA Received Date: 10/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1