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

Catalog Number G12160

Device Problems Break (1069); Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/22/2016

Event Type  malfunction  

Event Description

A 20 gauge 5 cm needle placed under mri guidance.Procedure completed.Surgeon pulled back needle to remove it at the end of case and the tip broke off.Provider was unable to retrieve the wire tip, which was disclosed to the patient.

• Brand Name: KOPANS BREAST LESION LOCALIZATION NEEDLE
• Type of Device: NEEDLE, TUMOR LOCALIZATION
• Manufacturer (Section D): COOK, INC.; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5849514
• MDR Text Key: 51262801
• Report Number: 5849514
• Device Sequence Number: 1
• Product Code: MIJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/01/2018
• Device Catalogue Number: G12160
• Device Lot Number: F4181874
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/29/2016
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 07/29/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR