General and Plastic Surgery · PMA · 2012
DUNE MEDICAL DEVICES MARGINPROBE SYSTEM
Dilon Medical Technologies, Ltd.. Approved by FDA on 27 December 2012 under submission P110014, product code OEE (diagnostic low electric field). What FDA's record says, in FDA's words.
Device record · P110014
- Device. DUNE MEDICAL DEVICES MARGINPROBE SYSTEMDEVICE
- Company. Dilon Medical Technologies, Ltd.COMPANY
- Decision. 27 December 2012, PMA, apprDECISION
- Panel. General and Plastic SurgeryPANEL
- Product code. OEE, Diagnostic Low Electric FieldCODE
- Source. FDA database entry · decision document (50 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA approved it for
The Indications for Use statement, verbatim, from the decision document.
The Dune MarginProbe System is an adjunctive diagnostic tool for iden tification of cancerous tissue at the margins (≤ 1mm) of the main ex-vivo lumpectomy specimen following primary excision and is indicated for intraoperative use, in conjunction with standard methods (such as intraoperative imaging and palpation) in patients undergoing breast lumpectomy surgery for previously diagnosed breast cancer.
The product code's definition, from FDA's classification record. As an adjunctive tool to guide the shavings of tissue at the margins of the tumor for use in excisional breast surgery to assist in locating the tissue for excision. In addition to other standard methods such as intraoperative imaging and palpation.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 1 report filed against devices carrying product code OEE. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
9 February 2016 · Malfunction · MARGINPROBE · DUNE MEDICAL DEVICES INC. · report 5418676
NURSES CONNECTED THE MARGIN PROBE TO THE MACHINE AS INSTRUCTED BY THE SURGEON . INITIALLY IT SEEMED TO WORK, AND THEN THE SCREEN SHOWED "FAILURE". MANUFACTURER RESPONSE FOR DUNN MARGIN PROBE X 2, DUNN (PER SITE REPORTER): THE REP WAS HERE TO CHECK THE MACHINE AND SEE IF THIS WAS THE ISSUE OR THE HAND PIECES AND IF THE MACHINE WAS WORKING CORRECTLY.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code OEE, in General and Plastic Surgery, or approved in 2012. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.