MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV DISPOSABLE HIGH SPEED TDC CUTTER 23G/8000 CPM DORC CONTINIUM RANGE

Catalog Number	8263.VIT23
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	03/31/2017
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 05/31/"201" this incident has occurred during surgery.Insufficient infusion in the line post prime but surgeon changed the set and continued with same issue.Insufficient infusion may lead to imbalance in the internal pressure of the eye since there was no error code shown to identify the issue.Hence this complaint is concluded as reportable.All available information has been disclosed.This complaint has now been closed.
Event or Problem Description
Our customer complained about the infusion line,which is only partial, through that the eye collapsed during vitrectomy.

• Brand Name: DISPOSABLE HIGH SPEED TDC CUTTER 23G/8000 CPM DORC CONTINIUM RANGE
• Common Device Name: DISPOSABLE HIGH SPEED TDC CUTTER 23G/8000 CPM DORC CONTINIUM RANGE
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7670033
• Report Number: 1222074-2018-00235
• Device Sequence Number: 18994020
• Product Code: HQE
• UDI-Device Identifier: 08717872020792
• UDI-Public: 08717872020792
• 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: distributor,foreign
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 03/31/2017

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: No Information
• Device Catalogue Number: 8263.VIT23
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2017
• Initial Report FDA Received Date: 07/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1