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	6268.NMD06
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation showed that the vitrectome was working according to our specifications and there was no damage found on the outside of the body.Only when there is no aspiration used, we noticed that a few microbubbles came out of the port.This complaint was determined to be reportable during the retrospective review.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) 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)(4)) during a tele-conference on (b)(6) 2017.All available information has been disclosed.The complaint is not confirmed.This complaint has now been closed.
Event or Problem Description
Customer is using a ust and the unit is running in the 2x mode with a stellaris pc ( 3500 ccp ).They use tdc vitrectomes and the complaint is that air bubbles comes out the cutter-hole in to the eye.Sample is available.

• 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: 7544465
• Report Number: 1222074-2018-00155
• Device Sequence Number: 1305375
• Product Code: HQE
• UDI-Device Identifier: 08717872008578
• UDI-Public: 08717872008578
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 02/22/2016

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: 6268.NMD06
• Device Lot Number: 2000370424
• 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: 02/22/2016
• Initial Report FDA Received Date: 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1