MAUDE Adverse Event Report: D.O.R.C INTERNATIONAL DISPOSABLE HIGH SPEED CUTTER 25G/8000CPM

Catalog Number	8267.VIT25
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	04/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation showed that the outer knife was loose, which caused the air bubbles and insufficient aspiration.This incident has occurred during surgery, formation of bubbles during surgery might lead to patient harm.Hence 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 cdrh office of compliance ((b)(6)) during a tele-conference on 05/31/2017.There is limited information on this incident and no information on the patient outcome or if they were harmed.
Event or Problem Description
This event occurred in (b)(6).According to our customer when using the vitrectome air bubbles were caused and the aspiration was insufficient.This event occurred during surgery.There is no information that the patient was injured or harmed.There is no information on the outcome of the patient.

• Brand Name: DISPOSABLE HIGH SPEED CUTTER 25G/8000CPM
• Common Device Name: DISPOSABLE HIGH SPEED CUTTER 25G/8000CPM
• Manufacturer (Section D): D.O.R.C INTERNATIONAL; scheijdelveweg 2; zuidland, netherlands 3214 VN; NL 3214 VN
• MDR Report Key: 6946383
• Report Number: 1222074-2017-00017
• Device Sequence Number: 1011470
• Product Code: HQE
• UDI-Device Identifier: 08717872019086
• UDI-Public: 08717872019086
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/17/2017

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.VIT25
• 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: 04/17/2014
• 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