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

Catalog Number G03507

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/16/2016

Event Type  malfunction  

Event Description

The tip of a breast lesion localization wire had broken inside the patient's breast.Provider was unable to locate and retrieve the tip when performing surgery.This was disclosed to the patient.

• Brand Name: KOPANS
• Type of Device: NEEDLE, TUMOR LOCALIZATION
• Manufacturer (Section D): COOK, INC.; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5757862
• MDR Text Key: 48433892
• Report Number: 5757862
• 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: 06/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/11/2021
• Device Catalogue Number: G03507
• Device Lot Number: 6807081
• Other Device ID Number: DKBL-21-7.0-A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/27/2016
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BILATERAL BREAST IMPLANTS PRESENT
• Patient Age: 27 YR
• Patient Weight: 59