MAUDE Adverse Event Report: D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV DISPOSABLE EVA IRRIGATION AND ASPIRATION TUBING

Catalog Number	8110.IAD01
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2014
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 (b)(4) during a tele-conference on 05/31/2017.It was identified that during the review, this is a surgical issue.Breakage of irrigation line can lead to collapse of anterior chamber or a hypotony and may have adverse effect on patient and hence this complaint can be categorised as reportable.No sample was returned.All available information has been disclosed.This complaint has now been closed.
Event or Problem Description
A report has been received regarding an incident that occurred in (b)(6).The following was reported: "the irrigation line broke during the i/a program.This is a serious problem as the anterior chamber could collapse as a result.".

• Brand Name: DISPOSABLE EVA IRRIGATION AND ASPIRATION TUBING
• Common Device Name: IRRIGATION AND ASPIRATION TUBING
• Manufacturer (Section D): D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV; scheijdelveweg 2; zuidland, netherlands 3214 VN; NL 3214 VN
• MDR Report Key: 7281844
• Report Number: 1222074-2018-00033
• Device Sequence Number: 10804066
• Product Code: HQE
• UDI-Device Identifier: 08717872019543
• UDI-Public: 08717872019543
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K142877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 11/06/2014

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: 8110.IAD01
• Device Lot Number: 2000365334
• 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: 11/06/2014
• 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