MAUDE Adverse Event Report: D.O.R.C INTERNATIONAL EVA VITRECTOMY PACK GRAVITY INPUT 25G

Model Number	8300.25G01
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was reported due to the vitrectome producing bubbles which is not acceptable.The possible harm is injury by microbial, viral or prion infection (patient harm).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 05/31/2017.All available information has been provided.No sample was returned for an evaluation, therefore this is not confirmed.This complaint has now been closed.
Event or Problem Description
This incident occurred during surgery from a facility in (b)(6).The following was reported: from aspiration port during vitrectomy, most of the time the air bubbles were coming away.The vitrectome was replaced, however, same problem.Then changed into 23g for anterior chamber.Again, air bubbles coming from aspiration port.When nurse put the vitrectome to cup with bss, pressed the footswitch, i saw air bubbles passing through the aspiration line to the cartridge, despite the aspiration port was fully sink in the bss.There is no further information.There is no report of patient ill effect.No sample was available.

• Brand Name: EVA VITRECTOMY PACK GRAVITY INPUT 25G
• Common Device Name: EVA VITRECTOMY PACK GRAVITY INPUT 25G
• Manufacturer (Section D): D.O.R.C INTERNATIONAL; scheijdelveweg 2; zuidland, netherlands 3214 VN; NL 3214 VN
• MDR Report Key: 7216946
• Report Number: 1222074-2018-00005
• Device Sequence Number: 13483540
• Product Code: HQE
• UDI-Device Identifier: 08717872019024
• UDI-Public: 08717872019024
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K142877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/04/2014

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 Model Number: 8300.25G01
• Device Catalogue Number: 8300.25G01
• Device Lot Number: 2000358435
• 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: 06/04/2014
• Initial Report FDA Received Date: 01/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1