MAUDE Adverse Event Report: D.O.R.C INTERNATIONAL DISPOSABLE ECKARDT ONE STEP VITRECTOMY KIT.(23 GAUGE / 0.6 MM)

Catalog Number	1272.ED205
Medical Device Problem Code	Physical Property Issue (3008)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/04/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have examined the instrument.The package was opened by the customer.We have just observed dust.This can not be done during production.Since everything is cleaned in the cleanroom.We can not trace the cause of the complaint.The white particle may lead to foreign body reaction and if used can lead to patient harm, hence can be concluded as reportable.This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer.(b)(4).Since this is a retrospective review, there is limited information.
Event or Problem Description
There is something like white solid material on the tip part of the trocar.Could you please let us know what the white solid material is, and the reason why this was attached? the sample is available for evaluation.No report of any harm to a patient.

• Brand Name: DISPOSABLE ECKARDT ONE STEP VITRECTOMY KIT.(23 GAUGE / 0.6 MM)
• Common Device Name: DISPOSABLE ECKARDT ONE STEP VITRECTOMY KIT.(23 GAUGE / 0.6 MM)
• Manufacturer (Section D): D.O.R.C INTERNATIONAL; scheijdelveweg 2; zuidland, netherlands 3214 VN; NL 3214 VN
• MDR Report Key: 6946222
• Report Number: 1222074-2017-00016
• Device Sequence Number: 1141218
• Product Code: HQC
• UDI-Device Identifier: 08717872002415
• UDI-Public: 08717872002415
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 03/04/2014

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: 1272.ED205
• Device Lot Number: 2000360112
• 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: 03/04/2014
• 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