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

Catalog Number	8267.VIT23
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/08/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No sample was returned, therefore unable to confirm this complaint.No information reasonably suggests a patient was harmed.In a retrospective review , since the bubbles are formed by the cutter 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 (dutch ophthalmic research centre (b)(4)).Details of this activity were discussed with cdrh office of compliance ((b)(6)) during a tele-conference on 05/31/2017.All available information has been provided.This complaint has now been closed.
Event or Problem Description
A report has been received reporting air bubbles.There is no further information.No sample available.

• Brand Name: DISPOSABLE HIGH SPEED CUTTER 23G/8000CPM
• Common Device Name: DISPOSABLE HIGH SPEED CUTTER 23G/8000CPM
• Manufacturer (Section D): D.O.R.C INTERNATIONAL BV; scheijdelveweg 2; zuidland, netherlands 3214 VN; NL 3214 VN
• MDR Report Key: 7222027
• Report Number: 1222074-2018-00014
• Device Sequence Number: 13903648
• Product Code: HQE
• UDI-Device Identifier: 08717872019093
• UDI-Public: 08717872019093
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K142877
• 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): 08/08/2014

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: 2000363299
• 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: 08/08/2014
• Initial Report FDA Received Date: 01/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1