FDA Adverse Event Injury Summary report: N

KOPANS BREAST LESION LOCALIZATION NEEDLE

MDR report key: 2596008 · Received May 25, 2012

Report

Report Number
MW5025580
Event Type
Injury
Date Received
May 25, 2012
Date of Event
March 27, 2012
Report Date
May 25, 2012
Manufacturer
COOK INCORPORATED
Product Code
MIJ
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
MD, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 KOPANS BREAST LESION LOCALIZATION NEEDLE KOPANS BREAST LESION LOCALIZATION NEEDLE MIJ COOK INCORPORATED 2847196

Patients

Seq Age Sex Outcome Treatment
1 44 YR Hospitalization