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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/16/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
Per (b)(4), reported through the fda voluntary event reporting process, the manufacturer was informed that during a wire localized partial mastectomy on a (b)(6) female patient, the tip of a breast lesion localization wire broke inside the patient's breast.The provider was unable to locate and retrieve the tip when performing surgery.This was disclosed to the patient.
Additional Manufacturer Narrative
Device product code: mij needle, tumor localization.Investigation results- a review of complaint history, manufacturing instructions, quality control measures, specifications and a review of trends was conducted to assist in the investigation.The device will not be returned to aid in the investigation of the alleged product failure.Since the device was not returned, examination could not be performed.Complaint will be confirmed based on customers testimony.This is the only complaint for this failure from 01jan2013 to 19oct2016 for this device.A definitive root cause could not be determined.The device history record was reviewed and no non-conformances were noted.There is no evidence to suggest that device was not manufactured according to specification.We will continue to monitor for similar complaints and have notified the appropriate personnel of this event.Per risk assessment no further actions are necessary at this time.

• 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: 5842796
• Report Number: 1820334-2016-00700
• Device Sequence Number: 16209932
• Product Code: MIJ
• UDI-Device Identifier: 00827002035072
• UDI-Public: (01)00827002035072(17)210311(10)6807081
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: DKBL-21-7.0-A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2016
• Supplement Report FDA Received Date: 01/25/2017
• 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
• Patient Age: 27 YR
• Patient Weight: 59