MAUDE Adverse Event Report: D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV DISPOSABLE PNEUMATIC VITRECTOME, 23 GAUGE

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	09/25/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This problem is known to us.We have improved the product causing this error to no longer occur.In a review of this complaint the source of the air bubbles is not known.The root cause is vi-o ring.If it is macro bubbles it can harm the patient seriously, hence considered reportable.The possible harm is injury by microbial, viral or prion infection (patient harm).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 ((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 provided.This complaint is now closed.
Event or Problem Description
A report has been received of an event that occurred in (b)(6).The bubble came out from the cutter port.Would it be possible to investigate carefully and let us know the cause? there is no further information and all has been disclosed.

• Brand Name: DISPOSABLE PNEUMATIC VITRECTOME, 23 GAUGE
• 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: 7278276
• Report Number: 1222074-2018-00027
• Device Sequence Number: 1847595
• Product Code: HQE
• UDI-Device Identifier: 08717872001418
• UDI-Public: 08717872001418
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/25/2014

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.NMD06
• 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: 09/25/2014
• Initial Report FDA Received Date: 02/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1