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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 25 G / 8000 CPM DORC CONTINUUM RANGE
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DUTCH OPTHALMIC RESEARCH CENTER BV DISPOSABLE HIGH SPEED TDC CUTTER 25 G / 8000 CPM DORC CONTINUUM RANGE Back to Search Results
Catalog Number 8268.VIT25
Medical Device Problem Codes Device Operational Issue (2914); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 04/15/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This complaint was reviewed during the retrospective review.The defect product was not returned, investigation is not possible, furthermore, no similar complaints were lodged on the same lot number.(b)(4).All available information has been disclosed.This complaint has now been closed.
 
Event or Problem Description
Air bubbles came out from 25g tdc cutter tip during peripheral shaving of an eye with detached retina.Cut rate:8000cpm, vacuum:650mmhg, flow:10cc/min, iv bottle height:50cm.
 
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Brand Name
DISPOSABLE HIGH SPEED TDC CUTTER 25 G / 8000 CPM DORC CONTINUUM RANGE
Common Device Name
DISPOSABLE HIGH SPEED TDC CUTTER 25 G / 8000 CPM DORC CONTINUUM RANGE
Manufacturer (Section D)
DUTCH OPTHALMIC RESEARCH CENTER BV
scheijdelveweg 2
zuidland, 3214V N
NL  3214VN
MDR Report Key7565058
Report Number1222074-2018-00164
Device Sequence Number19504888
Product Code HQE
UDI-Device Identifier08717872020808
UDI-Public08717872020808
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 company representative,distri
Initial Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date (Section B) 04/15/2016
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.VIT25
Device Lot Number2000375008
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 04/15/2016
Initial Report FDA Received Date06/04/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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