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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 23 G / 8000 CPM DORC CONTINUUM RANGE
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DUTCH OPTHALMIC RESEARCH CENTER BV DISPOSABLE HIGH SPEED TDC CUTTER 23 G / 8000 CPM DORC CONTINUUM RANGE Back to Search Results
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 04/07/2015
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Bubbles released from vitrectome during surgery would lead to patient harm, hence reportable.(b)(4).All available information has been provided.This complaint has now been closed.
 
Event or Problem Description
Our customer discovered bubbles when using 8268.Vit23.Incident occurred in (b)(6).
 
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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 Key7434944
Report Number1222074-2018-00081
Device Sequence Number84161
Product Code HQE
UDI-Device Identifier08717872020792
UDI-Public08717872020792
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K142877
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/07/2015
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.VIT23
Device Lot Number2000366914
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 04/07/2015
Initial Report FDA Received Date04/16/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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