MAUDE Adverse Event Report: D.O.R.C INTERNATIONAL DISPOSABLE HIGH SPEED CUTTER 20G/8000CPM; DISPOSABLE HIGH SPEED CUTTER 23G

Catalog Number	8267.VIT23
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/19/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The design of the vitrectomes has been changed after this lot number.Performance varies in- and out-of-specification.Since the bubbles are formed by the instrument during the surgery which can lead to microbial infection, this complaint is concluded as reportable.This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer.Details of this activity were discussed with (b)(4).Since this is a retrospective review there is limited information.
Event or Problem Description
American hospital had problem with the vitrectome due to air bubbles.There is no information of patient injury.There is no further information.Likely occurred during a surgery but we have no further information on the outcome of the patient.

• Brand Name: DISPOSABLE HIGH SPEED CUTTER 20G/8000CPM
• Common Device Name: DISPOSABLE HIGH SPEED CUTTER 23G
• Manufacturer (Section D): D.O.R.C INTERNATIONAL; scheijdelveweg 2; zuidland, netherlands 3214 VN; NL 3214 VN
• MDR Report Key: 6945668
• Report Number: 1222074-2017-00014
• Device Sequence Number: 796079
• Product Code: HQE
• UDI-Device Identifier: 08717872019093
• UDI-Public: 08717872019093
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/19/2014

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: 8267.VIT23
• Device Lot Number: 2000357261
• 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: 02/19/2014
• Initial Report FDA Received Date: 10/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1