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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV DISPOSABLE HIGH SPEED TDC CUTTER 27 G / 8000 CPM DORC CONTINUUM RANGE; EVA, COMBINED MACHINE INCLUDING LASER (DORC CONNECTOR)DISPOSABLE HIGH SPEED TDC
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DUTCH OPTHALMIC RESEARCH CENTER BV DISPOSABLE HIGH SPEED TDC CUTTER 27 G / 8000 CPM DORC CONTINUUM RANGE; EVA, COMBINED MACHINE INCLUDING LASER (DORC CONNECTOR)DISPOSABLE HIGH SPEED TDC Back to Search Results
Catalog Number 8268.VIT27
Medical Device Problem Code Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/07/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Dirt on the cutter can lead to patient harm.All available information has been disclosed.This complaint has now been closed.
 
Event or Problem Description
There was something on the cutter.
 
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Brand Name
DISPOSABLE HIGH SPEED TDC CUTTER 27 G / 8000 CPM DORC CONTINUUM RANGE
Common Device Name
EVA, COMBINED MACHINE INCLUDING LASER (DORC CONNECTOR)DISPOSABLE HIGH SPEED TDC
Manufacturer (Section D)
DUTCH OPTHALMIC RESEARCH CENTER BV
scheijdelveweg 2
zuidland, 3214V N
NL  3214VN
MDR Report Key7651440
Report Number1222074-2018-00212
Device Sequence Number19388570
Product Code HQE
UDI-Device Identifier08717872019659
UDI-Public08717872019659
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K142877
Number of Events Summarized1
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) 12/07/2016
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 Number8268.VIT27
Device Lot Number2000377774
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 12/07/2016
Initial Report FDA Received Date06/29/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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