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

Catalog Number	8523.210
Medical Device Problem Code	Physical Property Issue (3008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was reviewed during the retrospective review.The investigation showed that there are some small crack in the glue that holds the outer knife in the body.The root cause could not be determent and there the surface of the inner knife was damaged.For this a single point lessen for production will be.(b)(4).All available information has been disclosed.This complaint has now been closed.
Event or Problem Description
The complainant stated that the case started in vacuum mode and the cutter functioned properly.After switching to flow mode, air bubbles would come out of the cutter tip when the foot pedal was engaged.This continued upon switching back to vacuum mode.The air bubbles were particularly large.The connections were checked for tightness, and the cutter was tested in a cup of bss, and the bubbles continues.The cutter was then replaced and the case was finished without incident.There was no patient injury.The cutter is available for investigation.

• Brand Name: EVA CUSTOM TDC VITRECTOMY PACK VGPC INPUT 23G
• Common Device Name: EVA CUSTOM TDC VITRECTOMY PACK VGPC INPUT 23G
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7566163
• Report Number: 1222074-2018-00167
• Device Sequence Number: 19327904
• Product Code: HQE
• UDI-Device Identifier: 08717872008899
• UDI-Public: 08717872008899
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K142877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/09/2016

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 Catalogue Number: 8523.210
• Device Lot Number: 2000369683
• 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: 05/09/2016
• Initial Report FDA Received Date: 06/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1