MAUDE Adverse Event Report: COOK INC KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE; MIJ NEEDLE, TUMOR LOCALIZATION

Catalog Number	DKBL-20-9.0-A
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Pma/510(k) #: preamendment.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported a kopans modified breast lesion localization needle was not in the correct place for the surgeon.The patient was taken from the operating room to radiology where the radiologist placed a second marker.As reported, this incident caused a delay in the procedure, however, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Additional information was received on 20jun2018.It was determined this mfr.Report : 1820334-2018-01669 and mfr.Report: 1820334-2018-01663 are duplicate reports.The same patient, same device, one complaint.The patient had 2 tumors, one in the left breast and 1 in the right breast.One hook was implanted correctly, the issue occurred for one breast only.This event will be filed under mfr.Report: 1820334-2018-01663.Please cancel mfr.Report: 1820334-2018-01669 as a duplicate complaint.

• Brand Name: KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE
• Common Device Name: MIJ NEEDLE, TUMOR LOCALIZATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7582398
• Report Number: 1820334-2018-01669
• Device Sequence Number: 2515282
• Product Code: MIJ
• UDI-Device Identifier: 00827002025875
• UDI-Public: (01)00827002025875(17)230205(10)8562473
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: DKBL-20-9.0-A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 06/08/2018
• Supplement Report FDA Received Date: 08/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention