MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV DISPOSABLE HIGH SPEED CUTTER 23G/8000CPM

Catalog Number	8267.VIT23
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation showed no bubbles.Your bubbled may have been caused by the aspiration setting of the eva.In the future, put this stetting not on zero please.Incident occurred during surgery, vitrotome produced air bubbles which leads infection to patient which is a serious harm, hence concluded as reportable.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 (b)(4) 2017.All available information has been provided.This complaint is not confirmed and has now been closed.
Event or Problem Description
A report from iran has been received reporting the following: these probes were from the same lot number that we had bubbling problem with them.Samples are available.

• Brand Name: DISPOSABLE HIGH SPEED CUTTER 23G/8000CPM
• Common Device Name: DISPOSABLE HIGH SPEED CUTTER 23G/8000CPM
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7431849
• Report Number: 1222074-2018-00075
• Device Sequence Number: 16573146
• Product Code: HQE
• UDI-Device Identifier: 08717872019093
• UDI-Public: 08717872019093
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/05/2015

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: 8267.VIT23
• Device Lot Number: 2000364033
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2015
• Initial Report FDA Received Date: 04/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1