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 there was a minor damage on the inner knife, that may have caused the leakage.Production is informed to pay attention when assembling the cutter.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.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.The unit is running in the 2x mode with a stellaris pc ( 3500 ccp ).They use tdc vitrectomies and the complaint is that air bubbles come out the cutter hole in to the eye.There is no information suggesting patient harm.

• 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: 7542582
• Report Number: 1222074-2018-00154
• Device Sequence Number: 11126062
• Product Code: HQC
• UDI-Device Identifier: 08717872008578
• UDI-Public: 08717872008578
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Other
• 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: 2000368661
• 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: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1