MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV EVA VITRECTOMY PACK GRAVITY INPUT 27G

Catalog Number	8300.27G01
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/24/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There are no other complaints on this lot number.During the retrospective review, and as per the complaint description, incident occurred during surgery, vitrectome produced air bubbles during intake, which leads to serious harm to the patient, hence concluded as reportable.Assuming worst case during surgery, air bubbles observed may cause injury to the patient.Hence it is reportable.The risk is possible 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 (b)(6) 2017.No information reasonably suggests anyone was harmed.All available information has been disclosed.This complaint has now been closed.
Event or Problem Description
The vitrectome made a lot of bubbles.Air intake problem.No report of injury.All information has been disclosed.

• Brand Name: EVA VITRECTOMY PACK GRAVITY INPUT 27G
• Common Device Name: EVA VITRECTOMY PACK GRAVITY INPUT 27G
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7530336
• Report Number: 1222074-2018-00140
• Device Sequence Number: 16435223
• Product Code: HQE
• UDI-Device Identifier: 08717872019666
• UDI-Public: 08717872019666
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K142877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/24/2015

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: 8300.27G01
• Device Lot Number: 2000358477
• 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: 11/24/2015
• Initial Report FDA Received Date: 05/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1