MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV DISPOSABLE PNEUMATIC VITRECTOME.(23 GAUGE / 0.6 MM)(WORKING WITH 37 P.S.I., MAX.

Catalog Number	6267.NMD06
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/12/2017
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.V.).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/formed from the cutter can lead to patient harm.This may cause injury to the patient.Hence it is reportable.The risk is possible injury by microbial, viral or prion infection (patient harm).All available information has been disclosed.This complaint has now been closed.
Event or Problem Description
Air bubbles are coming out of the vitrectome (b)(4).

• Brand Name: DISPOSABLE PNEUMATIC VITRECTOME.(23 GAUGE / 0.6 MM)(WORKING WITH 37 P.S.I., MAX.
• Common Device Name: DISPOSABLE PNEUMATIC VITRECTOME.(23 GAUGE / 0.6 MM)(WORKING WITH 37 P.S.I., MAX.
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7655305
• Report Number: 1222074-2018-00220
• Device Sequence Number: 16181161
• Product Code: HQE
• UDI-Device Identifier: 08717872008578
• UDI-Public: 08717872008578
• 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): 01/12/2017

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: Physician
• Device Catalogue Number: 6267.NMD06
• Device Lot Number: 2000382853
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2017
• Initial Report FDA Received Date: 07/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1