MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV DISPOSABLE ONE STEP SINGLE CANNULA INCLUDING INSERTER. (27 GAUGE / 0.4 MM)

Catalog Number	1272.EDPP4
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/29/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation showed that there are gray particles on the inserter.The cannula and the closure valve where not return for investigation.The investigation could not reveal the root cause of this complaint.During the retrospective review the risk is foreign matter or foreign body reaction, hence concluded as reportable.(b)(4).All available information has been disclosed.This complaint has now been closed.
Event or Problem Description
A facility has reported that they found a gray particle on a trocar.

• Brand Name: DISPOSABLE ONE STEP SINGLE CANNULA INCLUDING INSERTER. (27 GAUGE / 0.4 MM)
• Common Device Name: DISPOSABLE ONE STEP SINGLE CANNULA INCLUDING INSERTER. (27 GAUGE / 0.4 MM)
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7533018
• Report Number: 1222074-2018-00143
• Device Sequence Number: 16557290
• Product Code: NGY
• 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: foreign,health professional,u
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 12/29/2015

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: 1272.EDPP4
• Device Lot Number: 2000368387
• 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: 12/29/2015
• Initial Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1