MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV EVA VITRECTOMY PACK GRAVITY INPUT 25G

Catalog Number	8300.25G01
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2015
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 (b)(6) 2017.The investigation showed that the body of the vitrectome has small cracks therefore the cap was able to come of.We have not found the root cause of the cracks yet.All available information has been disclosed.This complaint has now been closed.
Event or Problem Description
We are going to receive an official materiovigilance concerning vitrectome.The tip was ejected while it was inserted into the eye, fortunately there were no consequence for the patient.

• Brand Name: EVA VITRECTOMY PACK GRAVITY INPUT 25G
• Common Device Name: EVA VITRECTOMY PACK GRAVITY INPUT 25G
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7642826
• Report Number: 1222074-2018-00138
• Device Sequence Number: 13907793
• 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,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/09/2015

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: 8300.25G01
• Device Lot Number: 2000371555
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2015
• Initial Report FDA Received Date: 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1