MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER INTERNATIONAL BV DISPOSABLE PNEUMATIC VITRECTOME.(23 GAUGE / 0.6 MM)

Catalog Number	6267.NMD06
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/03/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Assuming worst case during surgery, air bubbles observed at the probe, may cause injury to the patient, hence it is reportable.The risk is possible injury by microbial, viral or prion infection (patient harm).This complaint occurred during surgery.Since the bubbles are formed by the cutter during the surgery which can lead to microbial infection, this complaint is concluded as reportable.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 that has reported the following incident: "the shandong distributor filed a complaint that the cutters released bubbles during the surgery.

• Brand Name: DISPOSABLE PNEUMATIC VITRECTOME.(23 GAUGE / 0.6 MM)
• Common Device Name: DISPOSABLE PNEUMATIC VITRECTOME.(23 GAUGE / 0.6 MM)
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER INTERNATIONAL BV; kerkweg 47e; p.o. box 43; zuidland,
• MDR Report Key: 7397153
• Report Number: 1222074-2018-00060
• Device Sequence Number: 723147
• Product Code: HQE
• UDI-Device Identifier: 08717872001418
• UDI-Public: 08717872001418
• Combination Product (Y/N): N
• 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): 02/03/2015

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.NMD06
• Device Lot Number: 2000359349
• 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: 02/03/2015
• Initial Report FDA Received Date: 04/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1