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	08/06/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No sample was returned, therefore unable to confirm this complaint.Since the bubbles are formed by the cutter during the surgery which can lead to microbial infection, this complaint is concluded as reportable.Investigation could not reveal the root cause, due to not receiving the faulty article.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 where bubbles came out of the cutter.It was reported that they think that the membrane is leaking.There is no report of patient injury or harm and it is unknown when this event occurred.No sample was returned for an evaluation.

• Brand Name: DISPOSABLE HIGH SPEED CUTTER 23G/8000CPM
• Common Device Name: DISPOSABLE HIGH SPEED CUTTER
• Manufacturer (Section D): D.O.R.C INTERNATIONAL BV; scheijdelveweg 2; zuidland, netherlands 3214 VN; NL 3214 VN
• MDR Report Key: 7222024
• Report Number: 1222074-2018-00013
• Device Sequence Number: 14021914
• Product Code: HQE
• UDI-Device Identifier: 08717872019093
• UDI-Public: 08717872019093
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K142877
• 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): 08/06/2014

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: 2000361779
• 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: 08/06/2014
• 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