MAUDE Adverse Event Report: D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL 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	09/22/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Incident happened during surgery, bubbles popping out from cutters hence concluded as reportable.The risk is injury by microbial, viral or prion infection (patient harm).There is no information that reasonably suggests a patient injury occurred.Investigation could not reveal the root cause, due to not receiving the faulty article.Therefore this complaint is closed.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.
Event or Problem Description
A report was received of an incident occurring in (b)(6).Previously,we also noticed the bubbles popping out from cutter.We simply change the cutter during the surgery.No further information is 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 DUTCH OPHTHALMIC INTERNATIONAL BV; scheijdelveweg 2; zuidland, netherlands 3214 VN; NL 3214 VN
• MDR Report Key: 7248907
• Report Number: 1222074-2018-00024
• Device Sequence Number: 13742634
• Product Code: HQE
• UDI-Device Identifier: 08717872019093
• UDI-Public: 08717872019093
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K142877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 09/22/2014

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?: No
• Operator of Device: Physician
• Device Catalogue Number: 8267.VIT23
• Device Lot Number: 2000363023
• 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: 09/22/2014
• Initial Report FDA Received Date: 02/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1