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

Model Number N/A

Device Problem Melted (1385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This event is currently under investigation.

Event Description

The surgeon was cauterizing around the lesion and the kopans melted.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.(b)(4).Investigation results - a review of the complaint history, manufacturing instructions (mi) and quality control (qc) documents was conducted for the purpose of this investigation.The product involved in this complaint has not been returned for evaluation.In addition, the product catalog and lot number are unknown and no images of the device(s) in question were provided.As such, a full investigation cannot be performed.The complaint is based off of the testimony provided by the customer.Kopans breast localization needles are produced per drawing according to instructions found in manufacturing instructions.Final inspection of the device is performed according per qc.Because the device was not returned, no images were provided, and the product rpn was not reported, a full investigation could not be performed and the complaint could not be confirmed via objective evidence.There are no signs that the device contained a manufacturing nonconformity.There is no evidence to suggest the device was not manufactured to specifications.A definitive root cause could not be determined.The root cause of this complaint is inconclusive.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.

Event Description

During the procedure, the surgeon was cauterizing around the lesion and the kopans melted.Additional information was requested, however it was not provided at the time of this report.

• Brand Name: KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE
• Type of Device: MIJ NEEDLE, TUMOR LOCALIZATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 5748636
• MDR Text Key: 48858983
• Report Number: 1820334-2016-00530
• 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: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 06/06/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other