MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV DISPOSABLE TWO STEP VITRECTOMY SYSTEM. (23 GAUGE/ 0.6 MM)

Catalog Number	1272.ED02
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	07/29/2015
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 lime stone effect happened due to the cyanoacrylate glue.This is discussed with the production department and the procedure has been changed.The associated risk is foreign body reaction, therefore upon retrospective review, this complaint was identified as reportable.The complaint is confirmed.All available information has been disclosed.The complaint has now been closed.
Event or Problem Description
It was reported the surgeon discovered white stains on the trocar.Sample is available.

• Brand Name: DISPOSABLE TWO STEP VITRECTOMY SYSTEM. (23 GAUGE/ 0.6 MM)
• Common Device Name: DISPOSABLE TWO STEP VITRECTOMY SYSTEM. (23 GAUGE/ 0.6 MM)
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7506755
• Report Number: 1222074-2018-00117
• Device Sequence Number: 11119142
• Product Code: HQC
• UDI-Device Identifier: 08717872003351
• UDI-Public: 08717872003351
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/29/2015

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.ED02
• Device Lot Number: 2000369084
• 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: 07/29/2015
• Initial Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1