MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY (SALIENT) INTACT CONSOLE (GEN 2); INSTRUMENT, BIOPSY

Model Number 900-101

Device Problems Bent (1059); Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2018

Event Type  malfunction  

Manufacturer Narrative

Product event: (b)(4).Patient information unable to be obtained despite a good faith effort made to obtain the information from the customer.If information is provided in the future, a supplemental report will be issued.

Event Description

During a breast oncology case, the surgeon was targeting the maker with the intact wand to remove the lesion and reported the wire on the device fractured; however, remained attached.This issue occurred a second time with an additional wand.

• Brand Name: INTACT CONSOLE (GEN 2)
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• Manufacturer (Section G): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• Manufacturer Contact: kaylee boisvert ; 180 international drive; portsmouth, NH 03801 ; 6038426234
• MDR Report Key: 7652468
• MDR Text Key: 112849393
• Report Number: 1226420-2018-00182
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152596
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 900-101
• Device Catalogue Number: 900-101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/28/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1