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

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	11/03/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Air bubbles observed at cutter port may cause injury to the patient.Hence it is reportable.The possible risks are injury by microbial, viral or prion infection (patient harm).There is no information of any patient injury occurring due to this event.No sample was returned, therefore unable to confirm this complaint.(b)(4).All available information has been provided.This complaint has now been closed.
Event or Problem Description
A report has been received of any incident that occurred in (b)(6).The following was reported: as discussed, during the vitrectomy demo during surgery, the cutter had bubbles popping out from the cutter port.All information has been disclosed.

• Brand Name: DISPOSABLE PNEUMATIC VITRECTOME
• 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: 7281243
• Report Number: 1222074-2018-00030
• Device Sequence Number: 956269
• Product Code: HQE
• UDI-Device Identifier: 08717872008578
• UDI-Public: 08717872008578
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 11/03/2014

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: 2000357480
• 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: 11/03/2014
• Initial Report FDA Received Date: 02/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1