MAUDE Adverse Event Report: D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV DISPOSABLE PNEUMATIC VITRECTOME.(25 GAUGE / 0.5 MM)

Catalog Number	6267.NMD05
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No sample was returned, therefore unable to confirm this complaint.Investigation could not reveal the root cause, due to not receiving the faulty article.Therefore this complaint is closed.Bubbles coming out of the cutter, hence concluded as reportable since it may lead to injury by microbial, viral or prion infection (patient harm).(b)(4).All available information has been provided.
Event or Problem Description
A report has been received of an event occurring in (b)(6).It was reported air bubble.There is no further information on this incident.No sample was saved.

• Brand Name: DISPOSABLE PNEUMATIC VITRECTOME.(25 GAUGE / 0.5 MM)
• Common Device Name: DISPOSABLE PNEUMATIC VITRECTOME
• Manufacturer (Section D): D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV; scheijdelveweg 2; zuidland, netherlands 3214 VN; NL 3214 VN
• MDR Report Key: 7245642
• Report Number: 1222074-2018-00019
• Device Sequence Number: 136195
• Product Code: HQE
• UDI-Device Identifier: 08717872017297
• UDI-Public: 08717872017297
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K081877
• 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): 08/13/2014

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.NMD05
• Device Lot Number: 2000357011
• 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: 08/13/2014
• Initial Report FDA Received Date: 02/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1