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

Catalog Number	8267.VIT20
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/03/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have extensively tested vitrectome.Our r & d department has made a change.As was already indicated in the snf, the new vitrectome will soon be available.Our csc department can tell when the new series is available.Since the bubbles are formed by the instrument during the surgery which can lead to microbial infection, this complaint is concluded as reportable.Performance varies in- and out-of-specification.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 cdrh office of compliance ((b)(6)) during a tele-conference on 05/31/2017.Since this is a retrospective review there is limited information.There is no information on the status of the patient.
Event or Problem Description
A report has been received from (b)(6) reporting the following event that the device has a loose handle and gives bubbles.Likely occurred during surgery.There is no information of any injury or outcome of the patient.The sample is available for an evaluation.

• Brand Name: DISPOSABLE HIGH SPEED CUTTER 20G/8000CPM
• Common Device Name: DISPOSABLE HIGH SPEED CUTTER 20G/8000CPM
• Manufacturer (Section D): D.O.R.C INTERNATIONAL; scheijdelveweg 2; zuidland, netherlands 3214 VN; NL 3214 VN
• MDR Report Key: 6945763
• Report Number: 1222074-2017-00015
• Device Sequence Number: 795400
• Product Code: HQE
• UDI-Device Identifier: 08717872019109
• UDI-Public: 08717872019109
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K081877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/03/2014

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: 8267.VIT20
• 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: 03/03/2014
• 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