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

Catalog Number	1272.ED06
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/13/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We have the tube where possible metal particle would be found.However, we unfortunately can not find any metal particle.The rest of the product was discarded by the customer, so we are not in the possibility to examine the product itself on abnormalities.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 05/31/2017.In the review of the risk, foreign metal piece may cause retinal tear.Hence it is reportable.This complaint is not confirmed.All available information has been disclosed.This complaint has now been closed.
Event or Problem Description
A report has been received of an event that occurred in (b)(6).It was learned "our technician informed us about the following complaint.When making the incision with the trocar system a piece of metal dropped into the eye when making the incision with the trocar system 1272.Ge206 of the above mentioned set, a piece of metal dropped into the eye on the retina.According to the surgeon the piece of metal came loose from the trocar itself.Luckily the surgeon could remove it from the eye fast, so we hope that there was no damage to the customer.A sample will be sent.All information has been disclosed.

• Brand Name: DISPOSABLE ECKARDT ONE STEP VITRECTOMY KIT.(23 GAUGE / 0.6 MM)
• Common Device Name: DISPOSABLE VITRECTOMY KIT
• Manufacturer (Section D): D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV; scheijdelveweg 2; zuidland, netherlands 3214 VN; NL 3214 VN
• MDR Report Key: 7283007
• Report Number: 1222074-2018-00038
• Device Sequence Number: 1177512
• Product Code: HQC
• UDI-Device Identifier: 08717872002415
• UDI-Public: 08717872002415
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 11/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: 1272.ED06
• Device Lot Number: 2000365219
• 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: 11/13/2014
• Initial Report FDA Received Date: 02/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other