MAUDE Adverse Event Report: D.O.R.C INTERNATIONAL BV EVA VITRECTOMY PACK GRAVITY INPUT 25G

Model Number	8300.25G01
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No sample was returned.This vitrectoom is before the change.This problem is known to us.New product was sent to this clinic with the latest specifications.This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer ((b)(4) 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.This complaint has now been closed.
Event or Problem Description
This incident occurred in (b)(6).We received a complaint from a clinic concerning the vitrectome included in pack with " bubbles " problems.No patient injury was reported.Information suggests this was detected during a surgical procedure, however no further information was provided.No sample is available.

• Brand Name: EVA VITRECTOMY PACK GRAVITY INPUT 25G
• Common Device Name: EVA VITRECTOMY PACK GRAVITY INPUT 25G
• Manufacturer (Section D): D.O.R.C INTERNATIONAL BV; scheijdelveweg 2; zuidland, netherlands 3214 VN; NL 3214 VN
• MDR Report Key: 7216936
• Report Number: 1222074-2018-00006
• Device Sequence Number: 1028025
• Product Code: HQE
• UDI-Device Identifier: 08717872019017
• UDI-Public: 08717872019017
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K142877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2014

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 Model Number: 8300.25G01
• Device Catalogue Number: 8300.25G01
• 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: 06/05/2014
• Initial Report FDA Received Date: 01/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1