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

Catalog Number	DKBL-20-5.0-A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: exempt.(b)(4).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 during a breast localization, a kopans modified breast lesion localization needle snapped when the surgeon manipulated it after it was placed.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, device history record, instructions for use (ifu), manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.We received only one small portion of the kopans breast localization needle back for investigation.Visual examination confirms damage to the surface of the needle.The distal loop appears to be in a damaged condition.Both proximal and distal areas exiting out of the noted cannula appears to be in a damaged condition.The proximal separated end appears to be elongated, twisted, and deformed.No biological matter is present throughout the length of the device.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Based on the information provided, examination of the returned product, and the results of our investigation, a definite root cause could not be determined.

• 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: 7450060
• Report Number: 1820334-2018-01019
• Device Sequence Number: 13796149
• Product Code: MIJ
• UDI-Device Identifier: 00827002025868
• UDI-Public: (01)00827002025868(17)220706(10)8043531
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DKBL-20-5.0-A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/06/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 06/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1