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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 Code Device Operational Issue (2914)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/19/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Assuming worst case during surgery, air bubbles observed at the probe.This may cause injury to the patient.Hence it is reportable.The risk is possible injury by microbial, viral or prion infection (patient harm).The lot is unknown therefore unable to perform a lot review.No sample was available for evaluation.The complaint is not confirmed.All available information has been disclosed.This complaint has now been closed.
 
Event or Problem Description
There was a lot of air bubbles coming out from the cutter.No sample.
 
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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 Key7655141
Report Number1222074-2018-00217
Device Sequence Number157233
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 distributor,foreign
Initial Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date (Section B) 12/19/2016
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
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 12/19/2016
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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