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

Catalog Number DKBL-20-5.0-A

Device Problem Break (1069)

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

Event Type  malfunction  

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 Description

The customer reported that the external wire of kopans modified breast lesion localization needle snapped off.The device did not remain in the patient's body.It was reported that the patient did not require any additional procedures and did not experience any adverse events.

Manufacturer Narrative

H10: additional information was received from the customer upon request.The customer confirmed that they could not confirm the length of the hook wire that snapped off.The customer also did not believe that the hook wire was bent at all.A1: (b)(6).Investigation/evaluation: a review of the documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly, a review of the device history record and complaint lot search could not be conducted.Ifu t_dkbl_rev2 states: contraindications: none known.Precautions: following placement of the hookwire, the portion protruding outside of the breast should be bent and taped to the skin to prevent inadvertent movement.Instructions for use.Introduce the needle into the lesion.Check the position of the needle.Remove the needle.Bend the hookwire protruding from the breast and tape flat to the skin.Verify final hookwire position.How supplied: upon removal from package, inspect the product to ensure no damage has occurred.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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
• MDR Report Key: 7450454
• MDR Text Key: 106632912
• Report Number: 1820334-2018-01142
• Device Sequence Number: 1
• Product Code: MIJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DKBL-20-5.0-A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1