KOPANS BREAST LESION LOCALIZATION NEEDLE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-05-25 for KOPANS BREAST LESION LOCALIZATION NEEDLE manufactured by Cook Incorporated.

Event Text Entries

[2644309] The pt is a (b)(6), female, scheduled for excision of localized abnormality of left breast. The interventional radiologist completed successful left breast localization using ultrasound guidance; the pt was then sent for mammography for confirmation of wire placement. The hook wire was identified traversing the left breast ovoid nodule at the 2:30 position. The pt was sent to the operating room with the mammography films. The operative note indicates the tissue was divided for approx two centimeters and then a core round the wire was taken, centered below the wire. On the lateral film the lesion was immediately below the wire and about two inches from the tip. The dissection was taken out past the tip of the wire and then the tissue was divided. The first x-ray showed that the lesion was probably there, but for extra assurance, the surgeon went back and took add'l tissue from along the side of the tract. The x-ray showed no add'l lesion in the second place, the layers were closed; the pt was wakened and taken to the post anesthesia care unit. Following protocol, the specimen and wire were sent to the radiologist for specimen study. The materials sent were the wire with adjacent specimen. However, the hook portion is not included on the examination. The surgeon was notified of these findings and the pt was sent for a mammogram. The impression identified a v-shaped foreign body compatible with hook portion of wire. The pt returned to the operating room for incision and removal of foreign body of left breast complex and was later discharged to home. Unk root cause product defect v provider technique.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5025580
MDR Report Key2596008
Date Received2012-05-25
Date of Report2012-05-25
Date of Event2012-03-27
Date Added to Maude2012-06-04
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameKOPANS BREAST LESION LOCALIZATION NEEDLE
Generic NameKOPANS BREAST LESION LOCALIZATION NEEDLE
Product CodeMIJ
Date Received2012-05-25
Lot Number2847196
ID NumberDKBL-20-7.0-A
Device Expiration Date2012-10-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerCOOK INCORPORATED
Manufacturer Address750 DANIEL'S WAY BLOOMINGTON IN 47404 US 47404


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2012-05-25

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