MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV DISP 23G TROCAR SYSTEM, STERIL

Catalog Number	1272.EDPP6
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Found foreign particle in cannula tip, there is a possibility of using the cannula, hence concluded as reportable.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.All available information has been disclosed.This complaint has now been closed.
Event or Problem Description
A report from (b)(6) has been received.The following has been reported: a piece of plastic (probably from the production process) at the tip of the trocar.The customer gave the particle to his microbiology.No further information.All information has been disclosed.

• Brand Name: DISP 23G TROCAR SYSTEM, STERIL
• Common Device Name: DISP 23G TROCAR SYSTEM, STERIL
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7430800
• Report Number: 1222074-2018-00072
• Device Sequence Number: 1095219
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/10/2018

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.EDPP6
• Device Lot Number: 2000365241
• 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: 02/10/2015
• Initial Report FDA Received Date: 04/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1