MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV DISPOSABLE HIGH SPEED TDC CUTTER 23 G / 8000 CPM DORC CONTINUUM RANGE

Catalog Number	8268.VIT23
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation was done on the returned cutter.The cutter was visually inspected, no deviations where found.The cutter was working according to specifications.Only when the aspiration was turned off bubbles appeared.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 (b)(6) "201" this incident occurred during surgery, air bubbles came out of vitrectomy which may lead to infection of eye, hence concluded as reportable.There is no information that reasonably suggests patient injury occurred.All available information has been disclosed.This complaint has now been closed.
Event or Problem Description
Bubble happens.Sample was saved and sent for evaluation.

• Brand Name: DISPOSABLE HIGH SPEED TDC CUTTER 23 G / 8000 CPM DORC CONTINUUM RANGE
• Common Device Name: DISPOSABLE HIGH SPEED TDC CUTTER 23 G / 8000 CPM DORC CONTINUUM RANGE
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7600729
• Report Number: 1222074-2018-00189
• Device Sequence Number: 232523
• Product Code: HQC
• UDI-Device Identifier: 08717872020792
• UDI-Public: 08717872020792
• 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: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 07/11/2016

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: 8268.VIT23
• Device Lot Number: 2000376248
• 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: 07/11/2016
• Initial Report FDA Received Date: 06/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1