MAUDE Adverse Event Report: D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV DISPOSABLE PNEUMATIC VITRECTOME, 25 GAUGE

Catalog Number	6267.NMD09
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/16/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Source of the air bubbles is not known.If it is macro bubbles it can harm the patient seriously.Hence considered reportable.No sample was returned, therefore unable to confirm this complaint.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.This complaint has now been closed.
Event or Problem Description
A report has been received from a facility located in (b)(6).The following was reported "air bubbles".There is no further information.

• Brand Name: DISPOSABLE PNEUMATIC VITRECTOME, 25 GAUGE
• Common Device Name: DISPOSABLE PNEUMATIC VITRECTOME, 25 GAUGE
• Manufacturer (Section D): D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV; scheijdelveweg 2; zuidland, netherlands 3214 VN; NL 3214 VN
• MDR Report Key: 7248624
• Report Number: 1222074-2018-00022
• Device Sequence Number: 11012302
• Product Code: HQE
• UDI-Device Identifier: 08717872017297
• UDI-Public: 08717872017297
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K081877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/16/2014

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 Catalogue Number: 6267.NMD09
• Device Lot Number: 2000362268
• 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: 09/16/2014
• Initial Report FDA Received Date: 02/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1