MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV EVA TDC VITRECTOMY PACK VGPC INPUT 23G

Model Number	8310.23G02
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2016
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 ((b)(4)).Details of this activity were discussed with cdrh office of compliance ((b)(6)) during a tele-conference on (b)(6).Assuming worst case during surgery, air bubbles observed at the probe.This may cause injury to the patient.Hence it is reportable.The risk is possible injury by microbial, viral or prion infection (patient harm).The customer indicated that no products will be returned for investigation.The lot is unknown therefore unable to review of the complaint database revealed that no similar complaints have been reported for this specific lot.There is no information that reasonably suggests patient injury occurred.All available information has been disclosed.This complaint has now been closed.
Event or Problem Description
While i was doing central vitrectomy big bubbles came out of the vitrectome port, this was not the very small bubbles i used to see in the first surgeries with the system, these are really big bubbles which even may cause damage to the crystalline lens and they don't let you work properly, the vitrectome is a bubble maker.

• Brand Name: EVA TDC VITRECTOMY PACK VGPC INPUT 23G
• Common Device Name: EVA TDC VITRECTOMY PACK VGPC INPUT 23G
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7621683
• Report Number: 1222074-2018-00193
• Device Sequence Number: 1422769
• Product Code: HQE
• UDI-Device Identifier: 08717872021010
• UDI-Public: 08717872021010
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 08/24/2016

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 Model Number: 8310.23G02
• Device Catalogue Number: 8310.23G02
• 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: 08/24/2018
• Initial Report FDA Received Date: 06/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1