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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
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DUTCH OPTHALMIC RESEARCH CENTER BV DISPOSABLE HIGH SPEED TDC CUTTER 27 G / 8000 CPM DORC CONTINUUM RANGE 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 01/11/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer (dutch ophthalmic research centre b.V.).Details of this activity were discussed with cdrh office of compliance ((b)(6)) during a tele-conference on (b)(6).The investigation showed that there is a silicone like residue on the tip of the vitrectome.The root cause of this issue could not be determined.All available information has been disclosed.This complaint has now been closed.
 
Event or Problem Description
There is something on the tip of the cutter.Please let us know what it is.Sample is available.
 
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Brand Name
DISPOSABLE HIGH SPEED TDC CUTTER 27 G / 8000 CPM DORC CONTINUUM RANGE
Common Device Name
DISPOSABLE HIGH SPEED TDC CUTTER 27 G / 8000 CPM DORC CONTINUUM RANGE
Manufacturer (Section D)
DUTCH OPTHALMIC RESEARCH CENTER BV
scheijdelveweg 2
zuidland, 3214V N
NL  3214VN
MDR Report Key7655168
Report Number1222074-2018-00219
Device Sequence Number10793586
Product Code HQE
UDI-Device Identifier08717872020815
UDI-Public08717872020815
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) 01/11/2017
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 Number8268.VIT27
Device Lot Number2000377774
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 01/11/2017
Initial Report FDA Received Date07/02/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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