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

Catalog Number	8300.23G02
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint occurred during surgery.The depression of anterior chamber was observed during mid of surgery.Hence this incident has been concluded as reportable.The risk identified based upon the description of the event is possible hypotony.There is no information that the involved patient was harmed or that hypotony had occurred.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 ((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 is now closed.
Event or Problem Description
The following incident has been reported by a clinic from (b)(6).The incident reportedly occurred during surgery.Due to a lack of irrigation there has been sudden depression of the anterior chamber.The tubing was blocked.No sample has been received.No further information is available.

• 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: 7218220
• Report Number: 1222074-2018-00009
• Device Sequence Number: 832805
• Product Code: HQE
• UDI-Device Identifier: 08717872019000
• UDI-Public: 08717872019000
• 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,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/23/2014

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: 8300.23G02
• Device Lot Number: 2000363002
• 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: 06/23/2014
• Initial Report FDA Received Date: 01/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1